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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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VariLift-L - 00813210020023

The Wenzel Spine VariLift Lumbar Interbody Fusion Device is a self-tapping, expandable device with an interior sliding wedge and a posterior end cap. The VariLift-L is a grooved and fluted device with large graft windows positioned each of its four quadrants that provide bony contact with the endplates. VariLift-L is designed to be implanted bi-laterally via posterior (PLIF) approach or as a single device via a transverse (TLIF) approach. VariLift-L may be implanted with or without supplemental fixation and is intended for use with autograft to facilitate fusion. VariLift-L is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.
Wenzel Spine, Inc.
CIE2-15-24-00
In Commercial Distribution

  • 00813210020023 ()

  • Length: 24 Millimeter
  • Outer Diameter: 15 Millimeter


  • Metallic spinal interbody fusion cage

VariLift-L - 00813210020016

The Wenzel Spine VariLift Lumbar Interbody Fusion Device is a self-tapping, expandable device with an interior sliding wedge and a posterior end cap. The VariLift-L is a grooved and fluted device with large graft windows positioned each of its four quadrants that provide bony contact with the endplates. VariLift-L is designed to be implanted bi-laterally via posterior (PLIF) approach or as a single device via a transverse (TLIF) approach. VariLift-L may be implanted with or without supplemental fixation and is intended for use with autograft to facilitate fusion. VariLift-L is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.
Wenzel Spine, Inc.
CIE2-13-24-00
In Commercial Distribution

  • 00813210020016 ()

  • Length: 24 Millimeter
  • Outer Diameter: 13 Millimeter


  • Metallic spinal interbody fusion cage

VariLift-L - 00813210020009

The Wenzel Spine VariLift Lumbar Interbody Fusion Device is a self-tapping, expandable device with an interior sliding wedge and a posterior end cap. The VariLift-L is a grooved and fluted device with large graft windows positioned each of its four quadrants that provide bony contact with the endplates. VariLift-L is designed to be implanted bi-laterally via posterior (PLIF) approach or as a single device via a transverse (TLIF) approach. VariLift-L may be implanted with or without supplemental fixation and is intended for use with autograft to facilitate fusion. VariLift-L is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.
Wenzel Spine, Inc.
CIE2-11-24-00
In Commercial Distribution

  • 00813210020009 ()

  • Length: 24 Millimeter
  • Outer Diameter: 11 Millimeter


  • Metallic spinal interbody fusion cage

Flouropassiv™ - 05037881011103

Fluoropassiv Gelatin Impregnated Thin Wall Knitted Carotid Patch TAPERED PATCH
VASCUTEK LTD
922512FT
Not in Commercial Distribution

  • 05037881011103 ()

  • Dimension 25 x 120 mm
922512FT

  • Cardiovascular patch, animal-derived

Flouropassiv™ - 05037881011097

Fluoropassiv Gelatin Impregnated Thin Wall Knitted Carotid Patch TAPERED PATCH
VASCUTEK LTD
921015FT
Not in Commercial Distribution

  • 05037881011097 ()

  • Dimension 10 x 150 mm
921015FT

  • Cardiovascular patch, animal-derived

Flouropassiv™ - 05037881011080

Fluoropassiv Gelatin Impregnated Thin Wall Knitted Carotid Patch TAPERED PATCH
VASCUTEK LTD
920611FT
Not in Commercial Distribution

  • 05037881011080 ()

  • Dimension 6 x 110 mm
920611FT

  • Cardiovascular patch, animal-derived

Flouropassiv™ - 05037881011073

Fluoropassiv Gelatin Impregnated Thin Wall Knitted Carotid Patch TAPERED PATCH
VASCUTEK LTD
921575FT
Not in Commercial Distribution

  • 05037881011073 ()

  • Dimension 15 x 75 mm
921575FT

  • Cardiovascular patch, animal-derived

Flouropassiv™ - 05037881011066

Fluoropassiv Gelatin Impregnated Thin Wall Knitted Carotid Patch TAPERED PATCH
VASCUTEK LTD
921550FT
Not in Commercial Distribution

  • 05037881011066 ()

  • Dimension 15 x 50 mm
921550FT

  • Cardiovascular patch, animal-derived

Flouropassiv™ - 05037881011059

Fluoropassiv Gelatin Impregnated Thin Wall Knitted Carotid Patch TAPERED PATCH
VASCUTEK LTD
921010FT
Not in Commercial Distribution

  • 05037881011059 ()

  • Dimension 10 x 100 mm
921010FT

  • Cardiovascular patch, animal-derived

Flouropassiv™ - 05037881011042

Fluoropassiv Gelatin Impregnated Thin Wall Knitted Carotid Patch TAPERED PATCH
VASCUTEK LTD
921075FT
Not in Commercial Distribution

  • 05037881011042 ()

  • Dimension 10 x 75 mm
921075FT

  • Cardiovascular patch, animal-derived

Flouropassiv™ - 05037881011035

Fluoropassiv Gelatin Impregnated Thin Wall Knitted Carotid Patch TAPERED PATCH
VASCUTEK LTD
921050FT
Not in Commercial Distribution

  • 05037881011035 ()

  • Dimension 10 x 50 mm
921050FT

  • Cardiovascular patch, animal-derived

Flouropassiv™ - 05037881011028

Fluoropassiv Gelatin Impregnated Thin Wall Knitted Carotid Patch TAPERED PATCH
VASCUTEK LTD
920875FT
Not in Commercial Distribution

  • 05037881011028 ()

  • Dimension 8 x 75 mm
920875FT

  • Cardiovascular patch, animal-derived

Flouropassiv™ - 05037881011011

Fluoropassiv Gelatin Impregnated Thin Wall Knitted Carotid Patch TAPERED PATCH
VASCUTEK LTD
920675FT
Not in Commercial Distribution

  • 05037881011011 ()

  • Dimension 6 x 75 mm
920675FT

  • Cardiovascular patch, animal-derived

Thinwall - 05037881010892

Thin Wall Carotid Patch Gelatin Impregnated Thin Wall Knitted Carotid Patch TAPERED PATCH
VASCUTEK LTD
922512T
In Commercial Distribution

  • 05037881010892 ()

  • Dimension 25 x 120 mm
922512T

  • Cardiovascular patch, animal-derived

Thinwall - 05037881010885

Thin Wall Carotid Patch Gelatin Impregnated Thin Wall Knitted Carotid Patch TAPERED PATCH
VASCUTEK LTD
921015T
In Commercial Distribution

  • 05037881010885 ()

  • Dimension 10 x 150 mm
921015T

  • Cardiovascular patch, animal-derived

Thinwall - 05037881010878

Thin Wall Carotid Patch Gelatin Impregnated Thin Wall Knitted Carotid Patch TAPERED PATCH
VASCUTEK LTD
921575T
In Commercial Distribution

  • 05037881010878 ()

  • Dimension 15 x 75 mm
921575T

  • Cardiovascular patch, animal-derived

Thinwall - 05037881010861

Thin Wall Carotid Patch Gelatin Impregnated Thin Wall Knitted Carotid Patch TAPERED PATCH
VASCUTEK LTD
921550T
In Commercial Distribution

  • 05037881010861 ()

  • Dimension 15 x 50 mm
921550T

  • Cardiovascular patch, animal-derived

Thinwall - 05037881010854

Thin Wall Carotid Patch Gelatin Impregnated Thin Wall Knitted Carotid Patch TAPERED PATCH
VASCUTEK LTD
921010T
In Commercial Distribution

  • 05037881010854 ()

  • Dimension 10 x 100 mm
921010T

  • Cardiovascular patch, animal-derived

Thinwall - 05037881010847

Thin Wall Carotid Patch Gelatin Impregnated Thin Wall Knitted Carotid Patch TAPERED PATCH
VASCUTEK LTD
921075T
In Commercial Distribution

  • 05037881010847 ()

  • Dimension 10 x 75 mm
921075T

  • Cardiovascular patch, animal-derived

Thinwall - 05037881010830

Thin Wall Carotid Patch Gelatin Impregnated Thin Wall Knitted Carotid Patch TAPERED PATCH
VASCUTEK LTD
921050T
In Commercial Distribution

  • 05037881010830 ()

  • Dimension 10 x 50 mm
921050T

  • Cardiovascular patch, animal-derived

Thinwall - 05037881010823

Thin Wall Carotid Patch Gelatin Impregnated Thin Wall Knitted Carotid Patch TAPERED PATCH
VASCUTEK LTD
920875T
In Commercial Distribution

  • 05037881010823 ()

  • Dimension 8 x 75 mm
920875T

  • Cardiovascular patch, animal-derived

Thinwall - 05037881010816

Thin Wall Carotid Patch Gelatin Impregnated Thin Wall Knitted Carotid Patch TAPERED PATCH
VASCUTEK LTD
920675T
In Commercial Distribution

  • 05037881010816 ()

  • Dimension 6 x 75 mm
920675T

  • Cardiovascular patch, animal-derived

Gelsoft™ Cardiovascular Patch - 05037881010700

Gelsoft Gelatin Impregnated Knitted Cardiovascular Patch
VASCUTEK LTD
961208
In Commercial Distribution

  • 05037881010700 ()

  • Dimensions 12 x 8 cm
961208

  • Cardiovascular patch, animal-derived

Gelsoft™ Cardiovascular Patch - 05037881010694

Gelsoft Gelatin Impregnated Knitted Cardiovascular Patch
VASCUTEK LTD
961204
In Commercial Distribution

  • 05037881010694 ()

  • Dimensions 12 x 4 cm
961204

  • Cardiovascular patch, animal-derived

Gelsoft™ Cardiovascular Patch - 05037881010687

Gelsoft Gelatin Impregnated Knitted Cardiovascular Patch
VASCUTEK LTD
960804
In Commercial Distribution

  • 05037881010687 ()

  • Dimensions 8 x 4 cm
960804

  • Cardiovascular patch, animal-derived

Gelsoft™ Cardiovascular Patch - 05037881010670

Gelsoft Gelatin Impregnated Knitted Cardiovascular Patch
VASCUTEK LTD
961001
In Commercial Distribution

  • 05037881010670 ()

  • Dimensions 10 x 1.5 cm
961001

  • Cardiovascular patch, animal-derived

Gelsoft™ Cardiovascular Patch - 05037881010663

Gelsoft Gelatin Impregnated Knitted Cardiovascular Patch
VASCUTEK LTD
961001S
In Commercial Distribution

  • 05037881010663 ()

  • Dimensions 10 x 1 cm
961001S

  • Cardiovascular patch, animal-derived

Gelsoft™ Cardiovascular Patch - 05037881010656

Gelsoft Gelatin Impregnated Knitted Cardiovascular Patch
VASCUTEK LTD
960701
In Commercial Distribution

  • 05037881010656 ()

  • Dimensions 7 x 1.5 cm
960701

  • Cardiovascular patch, animal-derived

Gelsoft™ Cardiovascular Patch - 05037881010649

Gelsoft Gelatin Impregnated Knitted Cardiovascular Patch
VASCUTEK LTD
960701S
In Commercial Distribution

  • 05037881010649 ()

  • Dimensions 7 x 1 cm
960701S

  • Cardiovascular patch, animal-derived

Gelsoft™ Cardiovascular Patch - 05037881010632

Gelsoft Gelatin Impregnated Knitted Cardiovascular Patch
VASCUTEK LTD
960603
In Commercial Distribution

  • 05037881010632 ()

  • Dimensions 6 x 3 cm
960603

  • Cardiovascular patch, animal-derived

Gelsoft™ Cardiovascular Patch - 05037881010625

Gelsoft Gelatin Impregnated Knitted Cardiovascular Patch
VASCUTEK LTD
960501
In Commercial Distribution

  • 05037881010625 ()

  • Dimensions 5 x 1.5 cm
960501

  • Cardiovascular patch, animal-derived

Gelsoft™ Cardiovascular Patch - 05037881010618

Gelsoft Gelatin Impregnated Knitted Cardiovascular Patch
VASCUTEK LTD
960501S
In Commercial Distribution

  • 05037881010618 ()

  • Dimensions 5 x 1 cm
960501S

  • Cardiovascular patch, animal-derived

Gelseal™ Cardiovascular Patch - 05037881010465

Gelseal Gelatin Impregnated Knitted Cardiovascular Patch
VASCUTEK LTD
951220
In Commercial Distribution

  • 05037881010465 ()

  • Dimensions 12 x 20 cm
951220

  • Cardiovascular patch, animal-derived

Gelseal™ Cardiovascular Patch - 05037881010458

Gelseal Gelatin Impregnated Knitted Cardiovascular Patch
VASCUTEK LTD
951208
In Commercial Distribution

  • 05037881010458 ()

  • Dimensions 12 x 8 cm
951208

  • Cardiovascular patch, animal-derived

Gelseal™ Cardiovascular Patch - 05037881010441

Gelseal Gelatin Impregnated Knitted Cardiovascular Patch
VASCUTEK LTD
951204
In Commercial Distribution

  • 05037881010441 ()

  • Dimensions 12 x 4 cm
951204

  • Cardiovascular patch, animal-derived

Gelseal™ Cardiovascular Patch - 05037881010434

Gelseal Gelatin Impregnated Knitted Cardiovascular Patch
VASCUTEK LTD
951020
In Commercial Distribution

  • 05037881010434 ()

  • Dimensions 10 x 20 cm
951020

  • Cardiovascular patch, animal-derived

Gelseal™ Cardiovascular Patch - 05037881010427

Gelseal Gelatin Impregnated Knitted Cardiovascular Patch
VASCUTEK LTD
951010
In Commercial Distribution

  • 05037881010427 ()

  • Dimensions 10 x 10 cm
951010

  • Cardiovascular patch, animal-derived

Gelseal™ Cardiovascular Patch - 05037881010410

Gelseal Gelatin Impregnated Knitted Cardiovascular Patch
VASCUTEK LTD
950804
In Commercial Distribution

  • 05037881010410 ()

  • Dimensions 8 x 4 cm
950804

  • Cardiovascular patch, animal-derived

Flouropassiv™ - 05037881003238

Fluoropassiv Gelatin Impregnated Thin Wall Knitted Carotid Patch VS125 TAPERED PATCH
VASCUTEK LTD
921020FTS
Not in Commercial Distribution

  • 05037881003238 ()

  • Dimension 10 x 200 mm
921020FTS

  • Cardiovascular patch, animal-derived

Thinwall - 05037881999227

Thin Wall Carotid Patch Gelatin Impregnated Thin Wall Knitted Carotid Patch TAPERED NO BLACK LINE
VASCUTEK LTD
920675TS
In Commercial Distribution

  • 05037881999227 ()

  • Dimension 6 x 75 mm
920675TS

  • Cardiovascular patch, animal-derived

BioRef-DC - 07290017249049

BIOFEEDBACK DEVICE BioRef-DC
TAVGER LTD
FG00019
In Commercial Distribution

  • 07290017249049 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system

2 Pack, Electrode Delivery Tool Kit - 00852184003618

No Description
Synapse Biomedical, Inc.
20-0074
In Commercial Distribution

  • 00852184003618 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system

Disposable Electrode Delivery Tool - 00852184003588

No Description
Synapse Biomedical, Inc.
21-0039-99
In Commercial Distribution

  • 00852184003588 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system

Electrode Delivery Tool Kit, MedCoat, HDE - 00852184003465

No Description
Synapse Biomedical, Inc.
22-0034
In Commercial Distribution

  • 00852184003465 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system

Airline Travel Battery Pack - 00852184003397

No Description
Synapse Biomedical, Inc.
22-0021
In Commercial Distribution

  • 00852184003397 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system

Electrode Delivery Tool Kit MedCoat, CE - 00852184003373

No Description
Synapse Biomedical, Inc.
22-0018
In Commercial Distribution

  • 00852184003373 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system

Silicone Adhesive Kit - 00852184003359

No Description
Synapse Biomedical, Inc.
22-0009
In Commercial Distribution

  • 00852184003359 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system

Connector Holder Kit - 00852184003342

No Description
Synapse Biomedical, Inc.
22-0004
In Commercial Distribution

  • 00852184003342 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system

Surgical Site Start-up Kit, ALS HDE - 00852184003328

No Description
Synapse Biomedical, Inc.
20-0070
In Commercial Distribution

  • 00852184003328 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system

System Destination Kit, 2-EPG, Canada - 00852184003311

No Description
Synapse Biomedical, Inc.
20-0065
In Commercial Distribution

  • 00852184003311 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system
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