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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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Equipment Cover 40" X 65" W/Tape
STERIMED LLC
4065X
In Commercial Distribution

  • 00867878000477 ()
  • 10867878000474 ()
  • 20867878000471 ()


  • X-ray system cover
3 Piece Tray Cover Pack - 1 - 24” X 28” Clear, 1 - 24” X 28” Red, 1 - 34” X 30” Clear (TC3B) Non-Sterile
STERIMED LLC
TC3B
In Commercial Distribution

  • 10867878000443 ()
  • 00867878000446 ()


  • X-ray system cover
Bag 5” X 14” (0514)
STERIMED LLC
0514
In Commercial Distribution

  • 20867878000433 ()
  • 10867878000436 ()
  • 00867878000439 ()


  • X-ray system cover
Band Bag 7" X 9" - 2 products/package (0284-2)
STERIMED LLC
0284-2
In Commercial Distribution

  • 20867878000419 ()
  • 10867878000412 ()
  • 00867878000415 ()


  • X-ray system cover
Restorative Posture Device with pads. Orthosis device used in conjunction with AMPCARE's Effective Swallowing Protocol (ESP) to enhance swallowing treatment by assisting with proper position of head and neck, maintaining placement and improving electrical conduction of E Series Electrodes and providing a resistive exercise protocol. For single patient use.
AMPCARE, LLC
RPD
In Commercial Distribution

  • 00867786000231 ()
50707

  • Cervicothoracic spine orthosis
bFed Starter kit containing 5 Large Cap Bolink™ Gravity Feeding Sets with ENFit® Connector (00867622000418), 2 Small Cap Bolink™ Gravity Feeding Sets with Cross Spike (00867622000401) and ENFit® Connectors and 3 375 mL Bolee™ Bags
U DELIVER MEDICAL L.L.C.
SK-2001
In Commercial Distribution

  • 00867622000449 ()
  • 00867622000463 ()
SK-2001

  • Enteral feeding kit, adult/paediatric, non-sterile
Small Cap Gravity Feeding Set with Cross Spike and ENFit Connector
U DELIVER MEDICAL L.L.C.
1085
In Commercial Distribution

  • 00867622000401 ()
  • 10867622000408 ()
  • 20867622000405 ()
1085

  • Enteral feeding kit, adult/paediatric, non-sterile
Foot examination tool for inflammatory changes.
Podimetrics, Inc.
PMHS201U-R
In Commercial Distribution

  • 00866538000314 ()
PMHS201U-R

  • Temperature telemetric monitoring system
The Procleix Software is one part of the Procleix Xpress System. The Procleix Xpress System (software and instrument) is intended to be used to create pools of  human plasma or serum for blood screening tests for viral nucleic acids. The Procleix Xpress System automatically transfers plasma or serum from individual samples into a single master pool tube, which may be used for further testing in Procleix systems. The Procleix Xpress System also collects barcode data from all tubes, racks, and archive plates used in a given pooling run, establishing positive specimen identification and Master Pool Tube (MPT) composition. In addition, the  Procleix Xpress System can be used to dispense human plasma or serum aliquots into an archive plate.
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Version 3.0
In Commercial Distribution

  • 00866489000036 ()
740769

  • Pipetting system
The Cassi Rotational Core Biopsy System with Quadpoint Disposable is used to perform biopsy pro-cedures on multiple patients. Up to 7 biopsy cycles (1 mandatory pre-test and 6 biopsies) can be performed per patient. The Cassi system components and catalog numbers are: REF: CS2100-NT Cassi Rotational Core Biopsy Needle – 10 gauge 10 – Sterile single-use biopsy needles and sample trays; comprised of a 19 gauge x 2 cm length securing needle with 10 gauge cutting cannula with trocar REF: CS2120-NT Cassi Rotational Core Biopsy Needle – 12 gauge 10 – Sterile single-use biopsy needles and sample trays; comprised of a 19 gauge x 2 cm length securing needle with a 12 gauge cutting cannula with trocar REF: CS2001-CC-10 10 – Non-sterile single-use CO2 (carbon dioxide) canisters with caps REF:CS2001-BH 1 – Non-sterile limited reusable biopsy handle and 1 spare limited-use 9 – volt alkaline battery
SCION MEDICAL TECHOLOGIES, LLC
CS-2001-CC-10
In Commercial Distribution

  • 00866479000152 ()


  • Soft-tissue biopsy needle, single-use
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