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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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VERASENSE - 00816818020419

No Description
ORTHOSENSOR INC
VERASENSE for Zimmer NexGen PS C-D/3-4
Not in Commercial Distribution

  • 00816818020419 ()
ZMR-NGPSCD34

  • Arthroplasty force sensor

PowerHeal Kit - 00810198031492

PowerHeal, 4"x4" Single Layer, & Energel
Vomaris Wound Care, Inc.
4"x4" SL, 4"x4" CD & Energel
In Commercial Distribution

  • 00810198031492 ()
PSK-4040-03

  • Bioelectric wound dressing

Procellera Power Pack - 00810198030426

Procellera Power Pack, 4"x4" Single Layer, 4"x4" Composite, & Energel
Vomaris Wound Care, Inc.
4"x4" SL, 4"x4" CD & Energel
In Commercial Distribution

  • 00810198030426 ()
VCK-0404-04

  • Bioelectric wound dressing

IHC - 00810170552762

No Description
Slmp, LLC
(BTO) Sample CD 23 (1B12) Antibody (2ml)
In Commercial Distribution

  • 00810170552762 ()
SAM-MM20-2

  • CD23 cell marker IVD, antibody

IHC - 00810170550898

CD23, Clone 1B12, 10mL
Slmp, LLC
(BTO) RTU CD 23 (1B12) Antibody (10ml)
In Commercial Distribution

  • 00810170550898 ()
MM20-10

  • CD23 cell marker IVD, antibody

Streck Cell Preservative - 20844509000840

An easy-to-use liquid preservative that maintains cellular antigen expression, including cluster of differentiation (CD) markers and cell morphology of biological samples for analysis by flow cytometry. Contains twenty four (24) 1.0 ml vials.
STRECK, INC.
213352
In Commercial Distribution

  • 20844509000840 ()
  • 00844509000846 ()

  • Total Volume: 1.0 Milliliter
213352

  • Lymphocyte stabilization reagent IVD

Norav 1200 Series PC-ECG - 07290110252540

Norav 1200 Series PC-ECG Software Kit with the following Option(s): - ECG Management System NEMS, Cloud Access to NEMS-Q The Kit includes: Software Protection Key - "HASP-Key" Software on Installation Medium (CD or USB-Stick).
NORAV MEDICAL LTD.
SW NEMS-CL
In Commercial Distribution

  • 07290110252540 ()
HASP-SW-K-NEMS-CL-01

  • Patient-administration information system application software

Welch Allyn, Inc. - 00732094308327

Surveyor Central Additional Control - configured CPU English language and CD manual; 110V power; 16 monitoring slots (dual or 24" display required with additional CPU); No printer; Color LCD 24" monitor with high resolution
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094308327 ()
SCAC-AAA-CXCXX

  • Centralized patient monitor

Welch Allyn, Inc. - 00732094347197

Surveyor Central Additional Control - configured CPU English language and CD manual; 110V power; 24 monitoring slots (dual or 24" display required with additional CPU); No printer; Color LCD 24" monitor with high resolution
WELCH ALLYN, INC.
901137
In Commercial Distribution

  • 00732094347197 ()
SCAC-AAA-DXCXX

  • Centralized patient monitor

TIMS System - 00850951007869

TIMS 2000 FEES connects to USB Endo scopes. Functionality includes static image and streaming capture, synced audio capture, DICOM send and receive, CD/DVD/USB burning. For FEES (Fiberoptic Endoscopic Evaluation of Swallowing) modalities.
FORESIGHT IMAGING, LLC
TIMS-FEES-USB 2A
Not in Commercial Distribution

  • 00850951007869 ()
061000-FEES-USB

  • Radiology picture archiving and communication system workstation
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