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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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Premier - D6911006735

ADAPTER NEEDLE 2 IN
PREMIER DENTAL PRODUCTS COMPANY
1006735
In Commercial Distribution

  • D6911006735 ()


  • General cryosurgical system, cryogen gas, mechanical

TiLock - M719GL5020

In Situ Bender 5.5mm
Genesys Orthopedics Systems LLC
1
In Commercial Distribution

  • M719GL5020 ()
GL502

  • Bone-screw internal spinal fixation system, non-sterile

Integra® - 10381780237341

Humeral Resurfacing Arthroplasty
Ascension Orthopedics, Inc.
SZR9005621
In Commercial Distribution

  • M269SZR90056211 ()
  • 10381780237341 ()

  • Size 56-21; 2.205 in dia
SZR-900-56-21

  • Surgical implant template, reusable

Integra® - 10381780237334

Humeral Resurfacing Arthroplasty
Ascension Orthopedics, Inc.
SZR9005221
In Commercial Distribution

  • M269SZR90052211 ()
  • 10381780237334 ()

  • Size 52-21; 2.047 in dia
SZR-900-52-21

  • Surgical implant template, reusable

Integra® - 10381780237327

Humeral Resurfacing Arthroplasty
Ascension Orthopedics, Inc.
SZR9005218
In Commercial Distribution

  • M269SZR90052181 ()
  • 10381780237327 ()

  • Size 52-18; 2.047 in dia
SZR-900-52-18

  • Surgical implant template, reusable

Integra® NuGrip® - 10381780237181

The Finishing Shaper is used to shape the implant.
Ascension Orthopedics, Inc.
SHP443S
In Commercial Distribution

  • M269SHP443S1 ()
  • 10381780237181 ()

  • Size Small; .405 in dia
SHP-443-S

  • Bone cutter

Integra® NuGrip® - 10381780237174

The Finishing Shaper is used to shape the implant.
Ascension Orthopedics, Inc.
SHP443M
In Commercial Distribution

  • M269SHP443M1 ()
  • 10381780237174 ()

  • Size Medium; .458 in dia
SHP-443-M

  • Bone cutter

Integra® NuGrip® - 10381780237167

The Finishing Shaper is used to shape the implant.
Ascension Orthopedics, Inc.
SHP443L
In Commercial Distribution

  • M269SHP443L1 ()
  • 10381780237167 ()

  • Size Large; .520 in dia
SHP-443-L

  • Bone cutter

Integra® PyroSphere® - 10381780236481

Trial used to evaluate the size and fit of the implant.
Ascension Orthopedics, Inc.
TRL43540
In Commercial Distribution

  • M269TRL435401 ()
  • 10381780236481 ()

  • Size 40; .589 in dia
TRL-435-40

  • Carpometacarpal interpositional spacer prosthesis trial

Integra® PyroSphere® - 10381780236474

Trial used to evaluate the size and fit of the implant.
Ascension Orthopedics, Inc.
TRL43530
In Commercial Distribution

  • M269TRL435301 ()
  • 10381780236474 ()

  • Size 30; .521 in dia
TRL-435-30

  • Carpometacarpal interpositional spacer prosthesis trial
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