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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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CM-hex screw system - 07640173090076

CM-hex screw system Cap screw CO M1.4 short
Cendres+Métaux SA
05000122
In Commercial Distribution

  • 07640173090076 ()

  • Length: 6.20 Millimeter
05000122

  • Dental prosthesis/implant abutment screw

Vision 2 - 00817978025856

Widal & Weil Felix Positive control Salmonella Paratyphi C-O
PRO-LAB, INCORPORATED
PLA585
In Commercial Distribution

  • 00817978025856 ()


  • Multiple Salmonella species culture isolate antigen IVD, reagent

Vision 2 - 00817978023036

Salmonella Paratyphi C-O Widal and Weil Felix Antigen
PRO-LAB, INCORPORATED
PLA303
In Commercial Distribution

  • 00817978023036 ()


  • Multiple Salmonella species culture isolate antigen IVD, reagent

Castable Abutment - 07290108816457

Co. Cr. Base Plastic Castable Abut, Pl.+Co.Cr.
NORIS MEDICAL LTD
NM-C2002
Not in Commercial Distribution

  • 07290108816457 ()
NM-C2002

  • Dental implant suprastructure, temporary, preformed, single-use

Starling SV - 07290013030030

A portable, non-invasive cardiac output (CO) monitoring device.
CHEETAH MEDICAL (ISRAEL) LTD
CMM-ST5
Not in Commercial Distribution

  • 07290013030030 ()
CMM-ST5

  • Multiple vital physiological parameter monitoring system, clinical

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

ACE - 00614950021840

TUMBLER 7OZ STAINLESS STEEL 2-7/8"X 3-1/8"
ACE SURGICAL SUPPLY CO., INC.
0531006
In Commercial Distribution

  • 00614950021840 ()
0531006

  • Medicine cup, reusable

NA - 04250869634724

MOSS VRS Locking Cap Inserter, star 27, AO coupling
Biedermann Motech GmbH & Co. KG
208-010-0205
In Commercial Distribution

  • 04250869634724 ()
208-010-0205

  • General internal orthopaedic fixation system implantation kit

ACE - 00614950026708

BUR TWIST 27MM .45HD 4CL CONTRA ANGLE
ACE SURGICAL SUPPLY CO., INC.
502700045
In Commercial Distribution

  • 00614950026708 ()

  • Length: 27 Millimeter
502700045

  • Carbide dental bur, reusable

ACE - 00614950009633

CONTRA ANGLE DRIVER FOR 5.0MM TRI-CAM SYSTEM SS 17-4 (H900)
ACE SURGICAL SUPPLY CO., INC.
04977901
In Commercial Distribution

  • 00614950009633 ()

  • Length: 27 Millimeter
04977901

  • Orthopaedic implant driver

ACE - 00614950009626

CONTRA ANGLE DRIVER FOR 4.3MM TRI-CAM SYSTEM SS 17-4 (H900)
ACE SURGICAL SUPPLY CO., INC.
04977701
In Commercial Distribution

  • 00614950009626 ()

  • Length: 27 Millimeter
04977701

  • Orthopaedic implant driver

ACE - 00614950021277

ONE PIECE CONNECTION TO THE CONTRA ANGLE FOR 3HD 27TL
ACE SURGICAL SUPPLY CO., INC.
04974101
In Commercial Distribution

  • 00614950021277 ()

  • Length: 27 Millimeter
04974101

  • Dental power tool converter attachment, rotary

Narcotrend Patient lead - 04260497025016

2-channel (4 electrodes) Component of Narcotrend-Compact M (Primary DI Number: 04260497021063)
MT MonitorTechnik GmbH & Co. KG
PKM4
In Commercial Distribution

  • 04260497025016 ()


  • Electroencephalographic monitoring system

Narcotrend Patient lead - 04260497025009

1-channel (3 electrodes) Component of Narcotrend-Compact M (Primary DI Number: 04260497021063)
MT MonitorTechnik GmbH & Co. KG
PKM1
In Commercial Distribution

  • 04260497025009 ()


  • Electroencephalographic monitoring system

Eikon - 00816728020752

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

  • 00816728020752 ()
C90W

  • Fibreoptic retractor handle

Side Rail Adapter & Extensions - 00887761971592

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

  • 00887761971592 ()


  • Medical device rail

Side Rail Adapter & Extensions - 00887761971424

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

  • 00887761971424 ()


  • Medical device rail

PEAKOSIL - 08800026400028

Product Name: PEAKOSIL Monophase Regular Set This product has another model number, NS024C.
NEOSIL Co., Ltd
MSRC
In Commercial Distribution

  • 18800026400025 ()
  • 08800026400028 ()
  • 08800026400349 ()


  • Silicone dental impression material

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

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

NEUWAVE - 00853719006487

CT Bed Rail Mount, Siemens Alt
NEUWAVE MEDICAL, INC.
CTBKT4
In Commercial Distribution

  • 00853719006487 ()

  • Depth: 88 Millimeter
  • Width: 645 Millimeter
CTBKT4

  • Microwave ablation system generator

Aequalis™ Ascend™ Flex - 03700386945335

No Description
TORNIER
DWF712C
In Commercial Distribution

  • 03700386945335 ()

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


  • Total reverse shoulder prosthesis

Aequalis™ Ascend™ Flex - 03700386945328

No Description
TORNIER
DWF712B
In Commercial Distribution

  • 03700386945328 ()

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


  • Total reverse shoulder prosthesis

Aequalis™ Ascend™ Flex - 03700386945311

No Description
TORNIER
DWF712A
In Commercial Distribution

  • 03700386945311 ()

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


  • Total reverse shoulder prosthesis

Aequalis™ Ascend™ Flex - 03700386944765

No Description
TORNIER
DWF611C
In Commercial Distribution

  • 03700386944765 ()

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


  • Total reverse shoulder prosthesis

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

NA - 10810030863448

Sterile Drape for MCM 2-Tier Back Table, 30 x 60" with upper shelf, 12 per case. Single use only.
MID CENTRAL MEDICAL CORP.
MCM555-DRAPE
In Commercial Distribution

  • 00810030863441 ()
  • 10810030863448 ()

  • Width: 50 Inch
  • Length: 88 Inch
MCM555-DRAPE

  • Medical equipment/instrument drape, single-use

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

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

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

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

Alcon Grieshaber 27+ - 07612717071353

27+® Advanced DSP Tip ILM Forceps
Alcon Laboratories, Inc.
727.44
In Commercial Distribution

  • 17612717071350 ()
  • 07612717071353 ()


  • Ophthalmic soft-tissue surgical forceps probe-tip, single-use

Alcon Grieshaber 27+ - 07612717071346

27+® Advanced DSP Tip EndgraspingForceps
Alcon Laboratories, Inc.
727.43
In Commercial Distribution

  • 17612717071343 ()
  • 07612717071346 ()


  • Ophthalmic soft-tissue surgical forceps probe-tip, single-use

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

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
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