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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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Table Clamp with Vertical Post - 10840199542243

Table Clamp with Vertical Post
KOROS U.S.A., INC.
9900-25
In Commercial Distribution

  • 00840199542246 ()
  • 10840199542243 ()

  • 9x12mm
9900-25

  • Surgical retractor/retraction system blade, reusable

ToggleLoc® with ZipLoop® - 00887868572548

No Description
Biomet Orthopedics, LLC
909849
In Commercial Distribution

  • 00887868572548 ()
909849

  • Ligament reconstruction instrument set, reusable

ToggleLoc® with ZipLoop® - 00887868572531

No Description
Biomet Orthopedics, LLC
909848
In Commercial Distribution

  • 00887868572531 ()
909848

  • Ligament reconstruction instrument set, reusable

Apheresis Needle with MASTERGUARD Protector - 00811137012411

Apheresis Needle with MASTERGUARD Protector 17 Ga. x 1-1/4'' BE. Sterile Fluid Path.
FENWAL, INC.
4R2441
Not in Commercial Distribution

  • 10811137012418 ()
  • 00811137012411 ()
4R2441

  • Apheresis system tubing set

Slide Hammer with Threaded Tip - 00887868480911

No Description
Biomet Orthopedics, LLC
31-473621
In Commercial Distribution

  • 00887868480911 ()
31-473621

  • Surgical mallet

ACTS (4.2oz/125ml with Dropper) - 00810929014787

Enzymatic detergents used to clean medical instruments.
Ruhof Corporation
34501-07
In Commercial Distribution

  • 00810929014879 ()
  • 00810929014787 ()


  • Medical device cleaning agent

ACTS (16.9oz/500ml with sprayer) - 00810929010338

Enzymatic detergents used to clean medical instruments.
Ruhof Corporation
34501-16
In Commercial Distribution

  • 00810929010345 ()
  • 00810929010338 ()


  • Medical device cleaning agent

ACTS (8.45oz/250ml with Dropper) - 00810929010543

Enzymatic detergents used to clean medical instruments.
Ruhof Corporation
34501-13
In Commercial Distribution

  • 00810929010550 ()
  • 00810929010543 ()


  • Medical device cleaning agent

dermaPACE System (Console with applicator) - 00812265010225

The dermaPACE console and applicator shipped together. An assembly of devices designed to provide high-energy, spark-gap generated (electrohydraulic) extracorporeal shock wave intended to treat diabetic foot ulers.
Sanuwave, Inc.
DEP0330/DAP0332
In Commercial Distribution

  • 00812265010225 ()


  • Dermatological extracorporeal shock wave therapy system

Sperm Washing Medium with HSA - 00810195240170

Modified HTF Medium with Human Serum Albumin (HSA). 100mL bottle.
IRVINE SCIENTIFIC, LLC
9983-100ML
In Commercial Distribution

  • 00810195240170 ()
9983

  • IVF medium
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