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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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ATRAMAT POLYPROPYLENE SURGICAL SUTURE BLUE USP 0 EP 3,5, 45 CM NEEDLE CE-24 REVERSE CUTTING 24 MM 3/8 CIRCLE
Internacional Farmacéutica, S.A. de C.V.
POLYPROPILENE
In Commercial Distribution

  • 07500142101984 ()
  • 07500142001987 ()

  • Length: 24 Millimeter
  • USP 0 EP 3,5
CE2461

  • Polyolefin/fluoropolymer suture, monofilament
Surveyor Central Repeater Node - English language and CD manual; 220V power; 0; Color LCD 24 in. monitor with high resolution
WELCH ALLYN, INC.
901011
In Commercial Distribution

  • 00732094285444 ()
SCREP-AAB-XXBXX

  • Centralized patient monitor
Lexie B2, Powered by Bose re-chargeable self-fitting hearing aid
HEARX GROUP (PTY) LTD
Lexie B2 Self-fitting OTC Hearing Aids Powered by Bose
In Commercial Distribution

  • 10850022464642 ()
  • 00850022464645 ()
In-Store

  • Air-conduction hearing aid, receiver-in-canal
Lexie B2, Powered by Bose re-chargeable self-fitting hearing aid
HEARX GROUP (PTY) LTD
LB2001
Not in Commercial Distribution

  • 00850022464638 ()
LBO00001B2

  • Air-conduction hearing aid, receiver-in-canal
OBALON Touch™ Dispenser - component to inflate the OBALON® Balloon
ReShape Lifesciences Inc.
4300-0003
Not in Commercial Distribution

  • 00859810006104 ()


  • Appetite-suppression gastric balloon inflation regulator
Nexcare™ Foot Protection Tape, FPT-05, 0 x 0 (0 x 0)
3M COMPANY
FPT-05
In Commercial Distribution

  • 50051141994975 ()
  • 30051141994971 ()
  • 00051141994970 ()
FPT-05

  • Hypoallergenic skin adhesive tape
Personalized PseudoPatient™ PV FL
RTSAFE, INC.
PFL-02PV
In Commercial Distribution

  • 00860001523218 ()
PFL-02PV

  • Custom-made organ/bone anatomy model
Personalized PseudoPatient™ PV IC
RTSAFE, INC.
PIC-02PV
In Commercial Distribution

  • 00860001523201 ()
PIC-02PV

  • Custom-made organ/bone anatomy model
The Brain Gauge MD is a computerized cognitive assessment aid that assesses cognitive function based on the perception of simple taps and vibrations delivered to the fingertips of the patient's hand.
CORTICAL METRICS, LLC
1.0
In Commercial Distribution

  • 00860000709408 ()

  • Depth: 73 Millimeter
  • Width: 113 Millimeter
  • Height: 40 Millimeter


  • Cognitive assessment software
HemaPrompt fecal occult blood test
AERSCHER, INC
HP
In Commercial Distribution

  • 00693501000220 ()
  • 00069350100022 ()


  • Faecal occult blood IVD, reagent
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