SEARCH RESULTS FOR: 2023(1891 results)

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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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PCRopsis - B5502820250

PCRopsis™ Reagent Buccal (25 mL) mediates extraction-free PCR from buccal specimens directly from swabs, without the need for transport medium.
ENTOPSIS, LLC
Reagent Buccal
Not in Commercial Distribution

  • B5502820250 ()
282025

  • Nucleic acid extraction/isolation kit IVD

PCRopsis - B5502668503

PCRopsis™ Concentrator (50 pre-loaded tubes) concentrates clinical samples.
ENTOPSIS, LLC
Concentrator
Not in Commercial Distribution

  • B55026685036 ()
  • B5502668503 ()
266850

  • Evaporation/filtration sample concentrator

PCRopsis - B55026682504

PCRopsis™ Concentrator (250 pre-loaded tubes) concentrates clinical samples.
ENTOPSIS, LLC
Concentrator
Not in Commercial Distribution

  • B550266825047 ()
  • B55026682504 ()
2668250

  • Evaporation/filtration sample concentrator

PCRopsis - B5502280010

PCRopsis™ Activator helps mediate room temperature Next Gen Direct PCR™
ENTOPSIS, LLC
Activator
Not in Commercial Distribution

  • B5502280010 ()
228001

  • Nucleic acid extraction/isolation kit IVD

PCRopsis - B550227610000

PCRopsis™ BCS Nano (1000 mL) is intended for selective precipitation of red blood cells from whole blood at room temperature.
ENTOPSIS, LLC
BCS Nano
Not in Commercial Distribution

  • B550227610000 ()
22761000

  • Red blood cell separation reagent

PCRopsis - B55022761000

PCRopsis™ BCS Nano (100 mL) is intended for selective precipitation of red blood cells from whole blood at room temperature.
ENTOPSIS, LLC
BCS Nano
Not in Commercial Distribution

  • B55022761000 ()
2276100

  • Red blood cell separation reagent

PCRopsis - B55022760100

PCRopsis™ BCS Nano (10 mL) is intended for selective precipitation of red blood cells from whole blood at room temperature.
ENTOPSIS, LLC
BCS Nano
Not in Commercial Distribution

  • B55022760100 ()
2276010

  • Red blood cell separation reagent

Nexxis - 05415334001626

MNA-240 DEC V2 AT
Barco NV
MNA-240
Not in Commercial Distribution

  • 05415334001626 ()
K9303271A

  • Operating room audiovisual data/device management system

Safety 1st - 00884392951825

5 SECOND RECTAL THERMOMETER
DOREL JUVENILE GROUP, INC.
TH111
In Commercial Distribution

  • 00884392951825 ()


  • Intermittent electronic patient thermometer

LAMEVEN Eye Massager - 06975977230016

No Description
Dongguan City Umed Technology Co., Ltd
MD-206
Not in Commercial Distribution

  • 16975977230013 ()
  • 06975977230016 ()


  • Eyelid massager

momcozy - 06975740360421

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

momcozy - 06975740360216

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

momcozy - 06975740360209

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

momcozy - 06975740360193

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

momcozy - 06975740360186

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

VaPro Pocket - 00610075090778

No Touch Urethral Intermittent Catheter, Hydrophilic, Coude Tip, Protective Tip and Sleeve
HOLLISTER INCORPORATED
77124
In Commercial Distribution

  • 10610075090775 ()
  • 00610075090778 ()
  • 20610075090772 ()

  • Catheter Gauge: 12 French
  • Length: 16 Inch


  • Single-administration urethral drainage catheter

Fibernex - B050LF0201X5500

Fibernex 550 micrometer Reusable Holmium Laser Fiber
TYPENEX MEDICAL LLC
LF0201X550
Not in Commercial Distribution

  • B050LF0201X5503 ()
  • B050LF0201X5500 ()

  • Outer Diameter: 550 Micrometer


  • Laser lithotripsy system

Fibernex - B050LF0201X3650

Fibernex 365 micrometer Reusable Holmium Laser Fiber
TYPENEX MEDICAL LLC
LF0201X365
Not in Commercial Distribution

  • B050LF0201X3653 ()
  • B050LF0201X3650 ()

  • Outer Diameter: 365 Micrometer


  • Laser lithotripsy system

Fibernex - B050LF0201X2720

Fibernex 272 micrometer Reusable Holmium Laser Fiber
TYPENEX MEDICAL LLC
LF0201X272
Not in Commercial Distribution

  • B050LF0201X2723 ()
  • B050LF0201X2720 ()

  • Outer Diameter: 272 Micrometer


  • Laser lithotripsy system

SMOOTHSKIN - 05060352783964

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

SMOOTHSKIN - 05060352782608

Light based Over-The-Counter Hair Removal
CYDEN LIMITED
SmoothSkin Pure
Not in Commercial Distribution

  • 05060352782837 ()
  • 05060352782608 ()


  • Home-use intense pulsed light hair removal unit

Lara System, 140 keV - 00850014578121

No Description
LUCERNO DYNAMICS, LLC
G
In Commercial Distribution

  • 00850014578121 ()
401874-100-2

  • Scintillation-counter radiation survey meter

Lara System, 511 keV - 00850014578114

No Description
LUCERNO DYNAMICS, LLC
G
In Commercial Distribution

  • 00850014578114 ()
401874-100-1

  • Scintillation-counter radiation survey meter

Lara Docking Station - 00850014578107

No Description
LUCERNO DYNAMICS, LLC
B
In Commercial Distribution

  • 00850014578251 ()
  • 00850014578107 ()
401874-285

  • Scintillation-counter radiation survey meter

Lara QC Fixture - 00850014578091

No Description
LUCERNO DYNAMICS, LLC
2
In Commercial Distribution

  • 00850014578268 ()
  • 00850014578091 ()
401874-200

  • Scintillation-counter radiation survey meter

Lara Sensor, Type 8 - 00850014578084

No Description
LUCERNO DYNAMICS, LLC
D
In Commercial Distribution

  • 00850014578244 ()
  • 00850014578084 ()
401874-220-8

  • Scintillation-counter radiation survey meter

Lara Sensor, Type 7 - 00850014578077

No Description
LUCERNO DYNAMICS, LLC
D
In Commercial Distribution

  • 00850014578237 ()
  • 00850014578077 ()
401874-220-7

  • Scintillation-counter radiation survey meter

Lara Sensor, Type 6 - 00850014578060

No Description
LUCERNO DYNAMICS, LLC
D
In Commercial Distribution

  • 00850014578220 ()
  • 00850014578060 ()
401874-220-6

  • Scintillation-counter radiation survey meter

Lara Sensor, Type 5 - 00850014578053

No Description
LUCERNO DYNAMICS, LLC
D
In Commercial Distribution

  • 00850014578213 ()
  • 00850014578053 ()
401874-220-5

  • Scintillation-counter radiation survey meter

Lara Sensor, Type 4 - 00850014578046

No Description
LUCERNO DYNAMICS, LLC
D
In Commercial Distribution

  • 00850014578206 ()
  • 00850014578046 ()
401874-220-4

  • Scintillation-counter radiation survey meter
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