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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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OPRA Implant System - 07340152101280

Axor Extension Plate 5 mm
Integrum AB
1165
In Commercial Distribution

  • 07340152101280 ()
1165

  • Internal-external leg prosthesis osseointegration bar

ENROUTE Transcarotid Stent - 00811311020386

5 mm X 40 mm
SILK ROAD MEDICAL, INC.
SR-0540-CS
In Commercial Distribution

  • 00811311020386 ()
SR-0540-CS

  • Bare-metal carotid artery stent

ENROUTE Transcarotid Stent - 00811311020379

5 mm X 30 mm
SILK ROAD MEDICAL, INC.
SR-0530-CS
In Commercial Distribution

  • 00811311020379 ()
SR-0530-CS

  • Bare-metal carotid artery stent

ENROUTE Transcarotid Stent - 00811311020362

5 mm X 20 mm
SILK ROAD MEDICAL, INC.
SR-0520-CS
In Commercial Distribution

  • 00811311020362 ()
SR-0520-CS

  • Bare-metal carotid artery stent

TheraSphere Y90 Glass Microspheres 5 GBq - 05060116920291

TheraSphere Yttrium-90 Glass Microspheres 5 GBq Dose
BIOCOMPATIBLES UK LTD
990700.SPE
Not in Commercial Distribution

  • 05060116920291 ()


  • Manual brachytherapy source, permanent implant

t:slim X2 5.x Insulin Pump - 00853052007981

t:slim X2 5.x Insulin Pump, Replacement, Refurbished
Tandem Diabetes Care, Inc.
1003808
In Commercial Distribution

  • 00853052007981 ()


  • Ambulatory insulin infusion pump/blood glucose analyser system

Minerva Argon Gas Canister (5 pack) - 00862393000131

Minerva Argon Gas Canister (offered in 5 pack)
Minerva Surgical, Inc.
MINARGC
In Commercial Distribution

  • 00862393000131 ()
  • 10862393000138 ()
MINARGC

  • Inert gas-enhanced endoscopic electrosurgical submucosal lift/resection instrument

2.7 x 8.0 mm screws [5] - M9575004220

2.7 x 8.0 mm screws [5]
Nexus Cmf, L.L.C.
500422
Not in Commercial Distribution

  • M9575004220 ()


  • Craniofacial bone screw, non-bioabsorbable

2.0 x 8.0 mm screws [5] - M9575004210

2.0 x 8.0 mm screws [5]
Nexus Cmf, L.L.C.
500421
Not in Commercial Distribution

  • M9575004210 ()


  • Craniofacial bone screw, non-bioabsorbable

2.0 x 6.0 mm screws [5] - M9575004200

2.0 x 6.0 mm screws [5]
Nexus Cmf, L.L.C.
500420
Not in Commercial Distribution

  • M9575004200 ()


  • Craniofacial bone screw, non-bioabsorbable
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