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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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Aequalis™ Ascend™ Flex - 03700386944758

No Description
TORNIER
DWF611B
In Commercial Distribution

  • 03700386944758 ()

  • Length: 88 Millimeter
  • Size 1B
  • Angle: 132.5 degree


  • Total reverse shoulder prosthesis

Aequalis™ Ascend™ Flex - 03700386944741

No Description
TORNIER
DWF611A
In Commercial Distribution

  • 03700386944741 ()

  • Length: 88 Millimeter
  • Size 1A
  • Angle: 127.5 degree


  • Total reverse shoulder prosthesis

Tornier Flex Shoulder System - 03700434022391

No Description
TORNIER
DWF712B
In Commercial Distribution

  • 03700434022391 ()

  • Length: 88 Millimeter
  • Angle: 132.5 degree
  • Size 2B
DWF712B

  • Total reverse shoulder prosthesis

Tornier Flex Shoulder System - 03700434022216

No Description
TORNIER
DWF611C
In Commercial Distribution

  • 03700434022216 ()

  • Angle: 137.5 degree
  • Size 1C
  • Length: 88 Millimeter
DWF611C

  • Total reverse shoulder prosthesis

Tornier Flex Shoulder System - 03700434022193

No Description
TORNIER
DWF611B
In Commercial Distribution

  • 03700434022193 ()

  • Angle: 132.5 degree
  • Size 1B
  • Length: 88 Millimeter
DWF611B

  • Total reverse shoulder prosthesis

Tornier Flex Shoulder System - 03700434022124

No Description
TORNIER
DWF712C
In Commercial Distribution

  • 03700434022124 ()

  • Angle: 137.5 degree
  • Size 2C
  • Length: 88 Millimeter
DWF712C

  • Total reverse shoulder prosthesis

Tornier Flex Shoulder System - 03700434020083

No Description
TORNIER
DWF611A
In Commercial Distribution

  • 03700434020083 ()

  • Size 1A
  • Length: 88 Millimeter
  • Angle: 127.5 degree
DWF611A

  • Total reverse shoulder prosthesis

Tornier Flex Shoulder System - 03700434019582

No Description
TORNIER
DWF712A
In Commercial Distribution

  • 03700434019582 ()

  • Length: 88 Millimeter
  • Size 2A
  • Angle: 127.5 degree
DWF712A

  • Total reverse shoulder prosthesis

NEUWAVE - 00818913020677

CT Bed Rail Mount, Flat
NEUWAVE MEDICAL, INC.
DR-001446
In Commercial Distribution

  • 00818913020677 ()

  • Depth: 88 Millimeter
  • Width: 645 Millimeter
CTBKT5

  • Microwave ablation system generator

E.M Adams co, inc. - 10840200309964

PELVIC HOLDER
E.M. ADAMS, INC.
EP60603XLPB-1
In Commercial Distribution

  • 50840200309955 ()
  • 10840200309964 ()

  • 27" x 17" body/ 1 1/2" x 72" strap/ 1 1/2" x 55" strap


  • Limb/torso/head restraint, reusable

E.M Adams co, inc. - 18100013409964

PELVIC HOLDER
E.M. ADAMS, INC.
EP60603XLPB-1
Not in Commercial Distribution

  • 58100013409955 ()
  • 18100013409964 ()

  • 27" x 17" body/ 1 1/2" x 72" strap/ 1 1/2" x 55" strap


  • Limb/torso/head restraint, reusable

Wiltrom Spinal Fixation System - 04719873027149

The Wiltrom Spinal Fixation System is comprised of screws, rods, cross-link connector and associated surgical instruments that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. The Wiltrom Spinal Fixation System is designed to be used to stabilize the vertebrae through a posterior approach. The Wiltrom spinal implants are made of Ti-6Al-4V ELI material which complies with ISO 5832-3 and ASTM F136. Wiltrom Spinal Fixation System is provided nonsterile, and the implants are for single use only.
WILTROM CO., LTD.
41006090 Rod with Taper Tip and Grooved End, Pre-bent ø=5.5 L=90
In Commercial Distribution

  • 04719873027149 ()


  • Bone-screw internal spinal fixation system rod

Side Rail Adapter & Extensions - 00887761971424

Side rail angled 90° U
Baxter Medical Systems GmbH + Co. KG
4500167
In Commercial Distribution

  • 00887761971424 ()


  • Medical device rail

Side Rail Adapter & Extensions - 00887761971592

Side rail extension angled 90°
Baxter Medical Systems GmbH + Co. KG
1218872
In Commercial Distribution

  • 00887761971592 ()


  • Medical device rail

N/A - 08809350897948

Compression Lag Screw, 15mm Sliding, 90 95mm
TDM Co., Ltd.
508-41095
In Commercial Distribution

  • 08809350897948 ()
508-41095

  • Femoral neck fixation sliding bone screw

Eikon - 00816728020752

LT Retractor, 90 mm, Wide
STRYKER CORPORATION
C90W
In Commercial Distribution

  • 00816728020752 ()
C90W

  • Fibreoptic retractor handle

LWT 88 LW RL (1dwt) - D818108081

Gold based noble metal
ARGEN CORPORATION, THE
108081
In Commercial Distribution

  • D818108081 ()
108081

  • Dental casting noble alloy

Reverso 88 Pin Tip Head - 07290018977057

No Description
INTELIS INSTRUMENTS LTD
IS-FG-00005
In Commercial Distribution

  • 07290018977057 ()


  • Radio-frequency skin contouring system applicator tip

ASSY,Reag.Disp.Card,PrepKit 88,BenchMark - 07613336127612

No Description
Ventana Medical Systems, Inc.
05252296001
In Commercial Distribution

  • 07613336127612 ()
05252296001

  • Assay container IVD, single-use

ASSY,Reag.Disp.Card,PrepKit 88,BenchMark - 07613336126059

No Description
Ventana Medical Systems, Inc.
05254094001
In Commercial Distribution

  • 07613336126059 ()
05254094001

  • Assay container IVD, single-use

BD BACTEC™ Platelet Anaerobic/F Culture Vials - 00382904420543

BD BACTEC™ Platelet Anaerobic/F Culture Vials
BECTON, DICKINSON AND COMPANY
442054
In Commercial Distribution

  • 30382904420544 ()
  • 00382904420543 ()

  • Total Volume: 40 Milliliter
442054

  • Culture medium antimicrobial supplement IVD

BD BACTEC™ Plus Aerobic/F Culture Vials - 00382904420239

BD BACTEC™ Plus Aerobic/F Medium
BECTON, DICKINSON AND COMPANY
442023
In Commercial Distribution

  • 30382904420230 ()
  • 00382904420239 ()

  • Total Volume: 30 Milliliter
442023

  • Culture medium antimicrobial supplement IVD

N/A - 20885403473200

Surgical Clipper Charging Adapter
CAREFUSION 2200, INC
5514A
In Commercial Distribution

  • 20885403473200 ()
  • 50885403473201 ()
5514A

  • Noninvasive device battery charger

N/A - 20885403473170

Surgical Clipper
CAREFUSION 2200, INC
5513E
In Commercial Distribution

  • 20885403473170 ()
  • 50885403473171 ()
5513E

  • Surgical hair clippers

Horizon™ - 10816843022300

DISPOSABLE HORIZON SUBDERMAL NEEDLE ELECTRODES: 27 GA., 12 MM BENT NEEDLE, 2.3 M (90") SINGLE LEADWIRE, COLOR GROUP C
ROCHESTER ELECTRO-MEDICAL, INC.
S94090-H
Not in Commercial Distribution

  • 10816843022317 ()
  • 10816843022300 ()


  • Subdermal needle electrode

DARCO® Posterior Splint - 00609271245396

L - 90° Plus White 90° Plus
Darco (Europe) GmbH
PS3-90-P1
In Commercial Distribution

  • 10609271245393 ()
  • 00609271245396 ()
  • 20609271245390 ()
PS3-90-P1

  • Ankle/foot orthosis

DARCO® Posterior Splint - 00609271245198

S - 90° Plus White 90° Plus
Darco (Europe) GmbH
PS1-90-P1
In Commercial Distribution

  • 20609271245192 ()
  • 00609271245198 ()
  • 10609271245195 ()
PS1-90-P1

  • Ankle/foot orthosis

DARCO® Posterior Splint - 00609271245297

M - 90° Plus White 90° Plus
Darco (Europe) GmbH
PS2-90-P1
In Commercial Distribution

  • 10609271245294 ()
  • 00609271245297 ()
  • 20609271245291 ()
PS2-90-P1

  • Ankle/foot orthosis

Earlens Wireless Programmer - 00850013007110

Software version is in Application Identifier (8012) Lot Number reflects software assembly/packaging lot number
EARLENS CORPORATION
WPUSB01
Not in Commercial Distribution

  • 00850013007110 ()
WPUSB01

  • Hearing aid/implant system programming interface unit

PhenomTM 27 Catheter - 00847536041882

CATHETER FG15160-0615-1S V04
Micro Therapeutics, Inc.
FG15160-0615-1S
In Commercial Distribution

  • 00847536041882 ()


  • Vascular microcatheter

PhenomTM 27 Catheter - 00847536041875

CATHETER FG15150-0630-1S V04
Micro Therapeutics, Inc.
FG15150-0630-1S
In Commercial Distribution

  • 00847536041875 ()


  • Vascular guide-catheter, single-use

PhenomTM 27 Catheter - 00847536041868

CATHETER FG15150-0615-1S V04
Micro Therapeutics, Inc.
FG15150-0615-1S
In Commercial Distribution

  • 00847536041868 ()


  • Vascular guide-catheter, single-use

PhenomTM 27 Catheter - 00847536041851

CATHETER FG15135-0615-1S V04
Micro Therapeutics, Inc.
FG15135-0615-1S
In Commercial Distribution

  • 00847536041851 ()


  • Vascular guide-catheter, single-use

REAMERS (2-7)-SHORT - D2483559961

Dental post reamer
HAGER WORLDWIDE, INC.
355996
In Commercial Distribution

  • D2483559960 ()
  • D2483559961 ()


  • Root canal post, preformed

PhenomTM 27 Catheter - 00763000399726

CATHETER FG15160-0615-1S V06 US
Micro Therapeutics, Inc.
FG15160-0615-1S
In Commercial Distribution

  • 00763000399726 ()


  • Vascular microcatheter

PhenomTM 27 Catheter - 00763000399719

CATHETER FG15150-0630-1S V06 US
Micro Therapeutics, Inc.
FG15150-0630-1S
In Commercial Distribution

  • 00763000399719 ()


  • Vascular guide-catheter, single-use

PhenomTM 27 Catheter - 00763000399702

CATHETER FG15150-0615-1S V06 US
Micro Therapeutics, Inc.
FG15150-0615-1S
In Commercial Distribution

  • 00763000399702 ()


  • Vascular guide-catheter, single-use

Alcon Grieshaber 27+ - 07612717071414

27+® Advanced DSP Backflush Soft Tip
Alcon Laboratories, Inc.
337.88
In Commercial Distribution

  • 17612717071411 ()
  • 07612717071414 ()


  • Vitrectomy fluid/gas handling handpiece/cannula

Alcon Grieshaber 27+ - 07612717071407

27+® Advanced DSP Backflush Blunt
Alcon Laboratories, Inc.
337.87
In Commercial Distribution

  • 17612717071404 ()
  • 07612717071407 ()


  • Vitrectomy fluid/gas handling handpiece/cannula

Alcon Grieshaber 27+ - 07612717071360

27+® Advanced DSP Tip Straight Scissors
Alcon Laboratories, Inc.
727.53
In Commercial Distribution

  • 17612717071367 ()
  • 07612717071360 ()


  • Intraocular scissors, probe-like, single-use
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