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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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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 - 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 - 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

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

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

STERILE Touchproof Cable, White - 00852184003182

No Description
Synapse Biomedical, Inc.
21-0026-99
In Commercial Distribution

  • 00852184003182 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system

STERILE Touchproof Cable Yellow - 00852184003175

No Description
Synapse Biomedical, Inc.
21-0025-99
In Commercial Distribution

  • 00852184003175 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system

STERILE Touchproof Cable, Orange - 00852184003168

No Description
Synapse Biomedical, Inc.
21-0024-99
In Commercial Distribution

  • 00852184003168 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system

STERILE Touchproof Cable, Green - 00852184003151

No Description
Synapse Biomedical, Inc.
21-0023-99
In Commercial Distribution

  • 00852184003151 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system

STERILE Trocar to Transducer Tubing - 00852184003137

No Description
Synapse Biomedical, Inc.
21-0010-99
In Commercial Distribution

  • 00852184003137 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system

STERILE Blue Cable Set - 00852184003120

No Description
Synapse Biomedical, Inc.
21-0009-99
In Commercial Distribution

  • 00852184003120 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system

STERILE Lead Tunnelers - 00852184003113

No Description
Synapse Biomedical, Inc.
21-0007-99
In Commercial Distribution

  • 00852184003113 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system

NeuRx DPS™ Surgical Kit, HDE - 00852184003038

No Description
Synapse Biomedical, Inc.
20-0028
In Commercial Distribution

  • 00852184003038 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system

NeuRx Diaphragm Pacing System - 00852184003007

No Description
Synapse Biomedical, Inc.
20-0035
In Commercial Distribution

  • 00852184003007 ()


  • Intramuscular diaphragm/phrenic nerve electrical stimulation system

Supple Peri-Guard - 00085412818696

SUPPLE PERI-GUARD is prepared from bovine pericardium cross-linked with glutaraldehyde, and treated with 1 molar sodium hydroxide for a minimum of 60 minutes at 20-25 degrees C. SUPPLE PERI-GUARD is terminally sterilized using gamma irradiation and packaged within a double-pouch system. The contents of the unopened, undamaged outer pouch are sterile.
SYNOVIS LIFE TECHNOLOGIES, INC.
SPG0406
In Commercial Distribution

  • 00085412818696 ()
SPG0406

  • Cardiovascular patch, animal-derived

Supple Peri-Guard - 00085412818672

SUPPLE PERI-GUARD is prepared from bovine pericardium cross-linked with glutaraldehyde, and treated with 1 molar sodium hydroxide for a minimum of 60 minutes at 20-25 degrees C. SUPPLE PERI-GUARD is terminally sterilized using gamma irradiation and packaged within a double-pouch system. The contents of the unopened, undamaged outer pouch are sterile.
SYNOVIS LIFE TECHNOLOGIES, INC.
SPG0404
In Commercial Distribution

  • 00085412818672 ()
SPG0404

  • Cardiovascular patch, animal-derived

Peri-Guard - 00085412818658

PERI-GUARD is prepared from bovine pericardium cross-linked with glutaraldehyde, and treated with 1 molar sodium hydroxide for a minimum of 60 minutes at 20-25 degrees C. PERI-GUARD is terminally sterilized using gamma irradiation and packaged within a double-pouch system. The contents of the unopened, undamaged outer pouch are sterile.
SYNOVIS LIFE TECHNOLOGIES, INC.
PG1225
In Commercial Distribution

  • 00085412818658 ()
PG1225

  • Cardiovascular patch, animal-derived

Vascu-Guard - 00085412818634

VASCU-GUARD is prepared from bovine pericardium cross-linked with glutaraldehyde, and treated with 1 molar sodium hydroxide for a minimum of 60 minutes at 20-25 degrees C. VASCU-GUARD is terminally sterilized using gamma irradiation. and packaged within a double-pouch system. The contents of the unopened, undamaged outer pouch are sterile.
SYNOVIS LIFE TECHNOLOGIES, INC.
VG02515
In Commercial Distribution

  • 00085412818634 ()
VG02515

  • Cardiovascular patch, animal-derived
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