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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SST DIAMOND V BLADE HALL(R) STYLE HUB
Microaire Surgical Instruments LLC
516055
Not in Commercial Distribution

  • 00847399017116 ()

  • Width: 25.4 Millimeter
  • Length: 85 Millimeter
  • Cutting Thickness: 1.4 mm


  • Surgical saw blade, sagittal, single-use
MICRO SAGITTAL, STRAIGHT BLADE
Microaire Surgical Instruments LLC
505338
Not in Commercial Distribution

  • 00847399017017 ()

  • Width: 9.4 Millimeter
  • Length: 25.4 Millimeter
  • Cutting Thickness: 0.6 mm


  • Surgical saw blade, sagittal, single-use
MICRO SAGITTAL STRAIGHT BLADE
Microaire Surgical Instruments LLC
505333
Not in Commercial Distribution

  • 00847399016997 ()

  • Width: 14 Millimeter
  • Length: 41 Millimeter
  • Cutting Thickness: 0.6 mm


  • Surgical saw blade, sagittal, single-use
ORTHOPOWER RECIP. TAPERED BLADE
Microaire Surgical Instruments LLC
277325
Not in Commercial Distribution

  • 00847399016973 ()

  • Width: 11.2 Millimeter
  • Length: 77.7 Millimeter
  • Cutting Thickness: 1 mm


  • Surgical saw blade, reciprocating, single-use
Light Based Over-The-Counter Hair Removal
CYDEN LIMITED
SmoothSkin Bare+
Not in Commercial Distribution

  • 05060352784145 ()
  • 05060352783964 ()


  • Home-use intense pulsed light hair removal unit
No Description
M.E.S. MEDICAL ELECTRONIC SYSTEMS LTD.
YO Universal 2.0 packed kit for BirdandBe - 2 tests
In Commercial Distribution

  • 07290016650587 ()
YO-FA-01912-00

  • Motile sperm concentration IVD, kit, imaging, self-testing
No Description
Dongguan City Umed Technology Co., Ltd
MD-206
Not in Commercial Distribution

  • 16975977230013 ()
  • 06975977230016 ()


  • Eyelid massager
The Wearable Breast Pump is intended to express milk from lactating women in order to collect breast milk from their breasts. The device is intended for a single user.
Shenzhen Lutejiacheng Technology Co., Ltd.
M5-Grey-D
In Commercial Distribution

  • 06975740369097 ()
  • 06975740360438 ()
  • 06975740360445 ()


  • Breast pump, electric
The Wearable Breast Pump is intended to express milk from lactating women in order to collect breast milk from their breasts. The device is intended for a single user.
Shenzhen Lutejiacheng Technology Co., Ltd.
M5-Grey
In Commercial Distribution

  • 06975740369103 ()
  • 06975740360421 ()


  • Breast pump, electric
The Wearable Breast Pump is intended to express milk from lactating women in order to collect breast milk from their breasts. The device is intended for a single user.
Shenzhen Lutejiacheng Technology Co., Ltd.
S12 Pro-white-D
In Commercial Distribution

  • 06975740369073 ()
  • 06975740360216 ()
  • 06975740369080 ()
  • 06975740360414 ()


  • Breast pump, electric
The Wearable Breast Pump is intended to express milk from lactating women in order to collect breast milk from their breasts. The device is intended for a single user.
Shenzhen Lutejiacheng Technology Co., Ltd.
S9 Pro-grey
In Commercial Distribution

  • 06975740369011 ()
  • 06975740360209 ()
  • 06975740369028 ()


  • Breast pump, electric
The Wearable Breast Pump is intended to express milk from lactating women in order to collect breast milk from their breasts. The device is intended for a single user.
Shenzhen Lutejiacheng Technology Co., Ltd.
S9 Pro-grey-D
In Commercial Distribution

  • 06975740369035 ()
  • 06975740360193 ()
  • 06975740369042 ()
  • 06975740360407 ()


  • Breast pump, electric
The Wearable Breast Pump is intended to express milk from lactating women in order to collect breast milk from their breasts. The device is intended for a single user.
Shenzhen Lutejiacheng Technology Co., Ltd.
S12 Pro-white
In Commercial Distribution

  • 06975740369059 ()
  • 06975740360186 ()
  • 06975740369066 ()


  • Breast pump, electric
No Description
Hong Qiangxing (Shen Zhen) Electronics Limited
TENS
In Commercial Distribution

  • 06971712724581 ()
  • 06971712724598 ()


  • Physical therapy transcutaneous neuromuscular electrical stimulation system
5 SECOND RECTAL THERMOMETER
DOREL JUVENILE GROUP, INC.
TH111
In Commercial Distribution

  • 00884392951825 ()


  • Intermittent electronic patient thermometer
MINOR PACK
MEDLINE INDUSTRIES, INC.
DYNJ46370K
In Commercial Distribution

  • 40195327272730 ()
  • 10195327272739 ()
DYNJ46370K

  • General surgical procedure kit, non-medicated, single-use
GENERAL LAPAROSCOPY PACK
MEDLINE INDUSTRIES, INC.
DYNJ46382N
In Commercial Distribution

  • 40195327272709 ()
  • 10195327272708 ()
DYNJ46382N

  • General surgical procedure kit, non-medicated, single-use
INFLIXIMAB SUPPLY KIT
MEDLINE INDUSTRIES, INC.
DYNDV2459A
In Commercial Distribution

  • 40195327272570 ()
  • 10195327272579 ()
DYNDV2459A

  • General surgical procedure kit, medicated
PK-ORTHO-SCOPE-FREVERT
MEDLINE INDUSTRIES, INC.
DYNJ45890B
In Commercial Distribution

  • 40195327266760 ()
  • 10195327266769 ()
DYNJ45890B

  • General surgical procedure kit, non-medicated, single-use
SHOULDER ARTHROSCOPY PACK
MEDLINE INDUSTRIES, INC.
DYNJ83421
In Commercial Distribution

  • 40195327265442 ()
  • 10195327265441 ()
DYNJ83421

  • General surgical procedure kit, non-medicated, single-use
SPINAL TRAY
MEDLINE INDUSTRIES, INC.
DYNJRA2099
In Commercial Distribution

  • 40195327305766 ()
  • 10195327305765 ()
DYNJRA2099

  • General surgical procedure kit, non-medicated, single-use
REGIONAL C-SECTION#144628-R-LF
MEDLINE INDUSTRIES, INC.
DYNJV0012R
In Commercial Distribution

  • 40195327302888 ()
  • 10195327302887 ()
DYNJV0012R

  • General surgical procedure kit, non-medicated, single-use
SPINNER KIT
MEDLINE INDUSTRIES, INC.
DYKE1656F
In Commercial Distribution

  • 40195327240104 ()
  • 10195327240103 ()
DYKE1656F

  • General surgical procedure kit, non-medicated, single-use
PODIATRY
MEDLINE INDUSTRIES, INC.
DYNJ903817F
In Commercial Distribution

  • 40195327308019 ()
  • 10195327308018 ()
DYNJ903817F

  • General surgical procedure kit, non-medicated, single-use
LAP CHOLE PACK
MEDLINE INDUSTRIES, INC.
DYNJ44157I
In Commercial Distribution

  • 40195327307173 ()
  • 10195327307172 ()
DYNJ44157I

  • General surgical procedure kit, non-medicated, single-use
FORAGE PACK
MEDLINE INDUSTRIES, INC.
DYNJ83958
In Commercial Distribution

  • 40195327319848 ()
  • 10195327319847 ()
DYNJ83958

  • General surgical procedure kit, non-medicated, single-use
INTUBATION KIT
MEDLINE INDUSTRIES, INC.
DYNJ83151A
In Commercial Distribution

  • 40195327319787 ()
  • 10195327319786 ()
DYNJ83151A

  • General surgical procedure kit, non-medicated, single-use
PACEMAKER PACK
MEDLINE INDUSTRIES, INC.
DYNJ24709C
In Commercial Distribution

  • 40195327319763 ()
  • 10195327319762 ()
DYNJ24709C

  • General surgical procedure kit, non-medicated, single-use
MINOR PACK
MEDLINE INDUSTRIES, INC.
DYNJ28847C
In Commercial Distribution

  • 40195327319718 ()
  • 10195327319717 ()
DYNJ28847C

  • General surgical procedure kit, non-medicated, single-use
WESTERN HEART PACK
MEDLINE INDUSTRIES, INC.
DYNJ23448D
In Commercial Distribution

  • 40195327319688 ()
  • 10195327319687 ()
DYNJ23448D

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