Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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WellSky Transfusion 2023 is a Blood Establishment Computer Software Product. Other than the packaging material/labeling. There is no hardware or other components included in the final product.WellSky Transfusion 2023 is intended to address all phases of transfusion services activities, and assists transfusion service personnel: • Manipulate and label products • Print ISBT 128 blood labels • Perform electronic cross match • Issue blood products under normal and emergency conditions • Receive and test patient and unit specimens • Interface to blood bank testing instruments (bi-directional) • Interface to blood storage device (bidirectional) WellSky Transfusion 2023 provides customized control processes for transfusion management of all procedures and testing on products and patients to reduce human error and enhance the ability to assure patient and product safety.
WELLSKY CORPORATION
2023
Not in Commercial Distribution

  • B105TRANSFUSION2023 ()


  • Blood bank information system application software
Blood Centers is a comprehensive, modular, computerized system intended to be used by trained personnel as a tool in the management of data processes performed by staff at blood centers and high-volume testing services. User access to individual modules is controlled through defined access levels. Individual staff may be actively engaged in functions that encompass the following: • Dynamic donor eligibility status • Register, track, and audit donations and deferrals • On-line health history, physical findings, and collection process • Inter-active donor questionnaire (staff and/or donor/remote donor) • HLA/RBC search and match • Donor schedules • Component production and modification • Testing • Labeling • Imported Blood Processing • Inventory Management • Distribution • Material Check-In • Offline Data Entry (Re-entry if downtime) • Blood Centers is usable with wired/wireless networks supporting TCP/IP protocols
WELLSKY CORPORATION
2023
In Commercial Distribution

  • B105BLOODCENTERS2023 ()


  • Blood bank information system application software
Calibration Standard Metanephrines
Chromsystems Instruments + Chemicals GmbH
2023
In Commercial Distribution

  • 04250317503114 ()

  • 10ml
2023

  • Multiple biogenic amine neurotransmitter IVD, calibrator
GEN4 Direct Access
CURBELL MEDICAL PRODUCTS, INC.
4C380U-Z103008
In Commercial Distribution

  • 00840828108041 ()
2023

  • Pillow speaker
A mains electricity (AC-powered), hand-held, device intended to be used to activate the polymerization of: 1) a dental resin-based material in the oral cavity; and/or 2) a surgical adhesive/sealant during an open-surgery procedure. It typically includes a light source [e.g., halogen, fluorescent, light-emitting diode (LED)] that emits light in the visible, or less frequently, ultraviolet spectrum, mounted in a handpiece that is typically attached to or used with a portable control unit or charging station.
DENT ZAR, INC.
1
In Commercial Distribution

  • D836PSLFH9 ()
2023

  • Dental/surgical polymerization lamp
truSculpt iD RF Device (Rebranded as truSculpt RF Device in June 2023)
CUTERA, INC.
truSculpt iD
In Commercial Distribution

  • 00816722021427 ()


  • Radio-frequency skin contouring system
ANA Nucleolar Positive Control - 2 x 1 ml
IMMUNO CONCEPTS INC
2023 (2)
In Commercial Distribution

  • M7490202321 ()
2023 (2)

  • Multiple antinuclear antibody (ANA) screening IVD, control
No Description
DIO Corporation
PP 2023
In Commercial Distribution

  • 08800049202197 ()


  • Dental guided surgery reference pin
TLIF(B) Trial L36 x W9 x H9
DIOMEDICAL CO.,LTD.
A
In Commercial Distribution

  • 08809557206031 ()
TI.2023

  • Spinal implant trial
Tinto Oct-2 is a rabbit monoclonal antibody derived from cell culture supernatant that is concentrated, dialyzed, filter sterilized and diluted in buffer pH 7.5
BIO SB, INC.
Predilute, 15 ml
In Commercial Distribution

  • L502BSB2023 ()
BSB 2023

  • Oct-2 IVD, antibody
Diffuser of ready-to-use liquid solutions
Amil Care Corp.
1L-2L-5L (hub)
In Commercial Distribution

  • G0602023T0 ()
2023.t

  • Airborne device-disinfectant diffuser
SINGLE SUNGLASS
Evolutioneyes, Inc.
NM SUN 2023
In Commercial Distribution

  • 00802807353927 ()


  • Tinted non-prescription spectacles
SINGLE SUNGLASS
Evolutioneyes, Inc.
ME SUN 2023
In Commercial Distribution

  • 00802807353910 ()


  • Tinted non-prescription spectacles
SINGLE SUNGLASS
Evolutioneyes, Inc.
MS SUN 2023
In Commercial Distribution

  • 00802807353903 ()


  • Tinted non-prescription spectacles
No Description
MedicalCommunications GmbH
2023 (Build 2088)
In Commercial Distribution

  • 04260648620039 ()


  • Ophthalmology PACS software
  • Radiology picture archiving and communication system workstation
  • Radiological PACS software
No Description
EYEVAN INC.
554 47 2023
In Commercial Distribution

  • 04571445049689 ()


  • Spectacle frame
No Description
EYEVAN INC.
414 46 2023
In Commercial Distribution

  • 04571445048651 ()


  • Spectacle frame
No Description
EYEVAN INC.
#414 46 2023
In Commercial Distribution

  • 04571445035347 ()


  • Spectacle frame
No Description
EYEVAN INC.
748 50 2023
In Commercial Distribution

  • 04571445051514 ()


  • Spectacle frame
SINGLE READER
Evolutioneyes, Inc.
4221 2023 DEMI MERLOT
In Commercial Distribution

  • 00802807355129 ()


  • Magnifying spectacles
Radiography 7000 M digital mobile is a new motorized mobile x-ray system that includes: 1. Base Unit ( Sedecal Mobile X-ray system - SM-IV, cleared under K232185 August 21, 2023) 2. SkyPlate Family of detectors (Wireless Portable Detectors) and their accessories 3. Eleva WorkSpot In addition, the following accessories can be used together with the system - Raidography 7000 M: - Detector Holder f. Patient Bed - Grid Landsc. SkyPlateE Large - Grid Landscape SkyPlate Large - Grid Portr. SkyPlate E Large - Grid Portrait SkyPlate Large - Grid Portrait SkyPlate Small - Handle for Skyplate Large - Portable Panel Protector - Wireless Detect. Mobile Holder - Set of 50 WPD Hygienic Bags (large) - Set of 50 WPD Hygienic Bags (small)
Philips Medical Systems DMC GmbH
712010
In Commercial Distribution

  • 00884838115521 ()


  • Mobile basic diagnostic x-ray system, digital
FHT HAND PACK
MEDLINE INDUSTRIES, INC.
DYNJ37123D
In Commercial Distribution

  • 40193489459303 ()
  • 10193489459302 ()
DYNJ37123D

  • General surgical procedure kit, non-medicated, single-use
VENCLOSE MICRO INTRO KIT, 12CM
MEDLINE INDUSTRIES, INC.
VC-ISH-6F12
In Commercial Distribution

  • 40193489377355 ()
  • 10193489377354 ()
VC-ISH-6F12

  • General surgical procedure kit, non-medicated, single-use
VENCLOSE MICRO INTRO KIT, 7CM
MEDLINE INDUSTRIES, INC.
VC-ISH-6F7
In Commercial Distribution

  • 40193489377195 ()
  • 10193489377194 ()
VC-ISH-6F7

  • General surgical procedure kit, non-medicated, single-use
HAND PACK
MEDLINE INDUSTRIES, INC.
DYNJ45039D
In Commercial Distribution

  • 40193489216012 ()
  • 10193489216011 ()
DYNJ45039D

  • General surgical procedure kit, non-medicated, single-use
TOTAL KNEE - GB
MEDLINE INDUSTRIES, INC.
DYNJ906711C
In Commercial Distribution

  • 10193489428988 ()
DYNJ906711C

  • General surgical procedure kit, non-medicated, single-use
PK, NEURO-MINOR
MEDLINE INDUSTRIES, INC.
DYNJ67760
In Commercial Distribution

  • 40193489429368 ()
  • 10193489429367 ()
DYNJ67760

  • General surgical procedure kit, non-medicated, single-use
PK, ENT
MEDLINE INDUSTRIES, INC.
DYNJ43875B
In Commercial Distribution

  • 40193489427876 ()
  • 10193489427875 ()
DYNJ43875B

  • General surgical procedure kit, non-medicated, single-use
VENCLOSE PROCEDURE PACK, 12CM
MEDLINE INDUSTRIES, INC.
VC-PPH-6F12A
In Commercial Distribution

  • 40193489423106 ()
  • 10193489423105 ()
VC-PPH-6F12A

  • General surgical procedure kit, non-medicated, single-use
VENCLOSE PROCEDURE PACK, 7CM
MEDLINE INDUSTRIES, INC.
VC-PPH-6F7A
In Commercial Distribution

  • 40193489423090 ()
  • 10193489423099 ()
VC-PPH-6F7A

  • General surgical procedure kit, non-medicated, single-use
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