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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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FLASH Ostial System OTW - M917OTW7017BA0

FLASH Ostial System, Dual Balloon Angioplasty Catheter, 0.035" OVER-THE-WIRE, 7.0mm x 17mm
Verge Medical, Inc.
OTW7017BA
In Commercial Distribution

  • M917OTW7017BA0 ()

  • Catheter Length: 135cm
  • Distal Balloon Length: 17mm
  • Distal Balloon Diameter: 7.0mm
OTW7017BA

  • Peripheral angioplasty balloon catheter, basic

FLASH Ostial System OTW - M917OTW7012BA0

FLASH Ostial System, Dual Balloon Angioplasty Catheter, 0.035" OVER-THE-WIRE, 7.0mm x 12mm
Verge Medical, Inc.
OTW7012BA
In Commercial Distribution

  • M917OTW7012BA0 ()

  • Distal Balloon Diameter: 7.0mm
  • Distal Balloon Length: 12mm
  • Catheter Length: 135cm
OTW7012BA

  • Peripheral angioplasty balloon catheter, basic

FLASH Ostial System OTW - M917OTW6012BA0

FLASH Ostial System, Dual Balloon Angioplasty Catheter, 0.035" OVER-THE-WIRE, 6.0mm x 12mm
Verge Medical, Inc.
OTW6012BA
In Commercial Distribution

  • M917OTW6012BA0 ()

  • Catheter Length: 135cm
  • Distal Balloon Length: 12mm
  • Distal Balloon Diameter: 6.0mm
OTW6012BA

  • Peripheral angioplasty balloon catheter, basic

FLASH Ostial System - M917OAB7019BA0

FLASH Ostial System, Dual Balloon Angioplasty Catheter, 7.0mm x 17mm
Verge Medical, Inc.
OAB7019BA
In Commercial Distribution

  • M917OAB7019BA0 ()

  • Catheter Length: 135cm
  • Distal Balloon Length: 17mm
  • Distal Balloon Diameter: 7.0mm
OAB7019BA

  • Peripheral angioplasty balloon catheter, basic

FLASH Ostial System - M917OAB6019BA0

FLASH Ostial System, Dual Balloon Angioplasty Catheter, 6.0mm x 17mm
Verge Medical, Inc.
OAB6019BA
In Commercial Distribution

  • M917OAB6019BA0 ()

  • Distal Balloon Diameter: 6.0mm
  • Distal Balloon Length: 17mm
  • Catheter Length: 135cm
OAB6019BA

  • Peripheral angioplasty balloon catheter, basic

FLASH Ostial System - M917OAB6014BA0

FLASH Ostial System, Dual Balloon Angioplasty Catheter, 6.0mm x 12mm
Verge Medical, Inc.
OAB6014BA
In Commercial Distribution

  • M917OAB6014BA0 ()

  • Catheter Length: 135cm
  • Distal Balloon Length: 12mm
  • Distal Balloon Diameter: 6.0mm
OAB6014BA

  • Peripheral angioplasty balloon catheter, basic

Passeo-35 - 07640130435766

No Description
Biotronik AG
3/170/130
Not in Commercial Distribution

  • 07640130435766 ()

  • Length: 170 mm
  • Usable Length: 130 cm
  • Diameter: 3 mm
389778

  • Peripheral angioplasty balloon catheter, basic

Passeo-35 - 07640130435759

No Description
Biotronik AG
3/150/130
Not in Commercial Distribution

  • 07640130435759 ()

  • Diameter: 3 mm
  • Length: 150 mm
  • Usable Length: 130 cm
389777

  • Peripheral angioplasty balloon catheter, basic

Passeo-35 - 07640130435742

No Description
Biotronik AG
3/170/90
Not in Commercial Distribution

  • 07640130435742 ()

  • Length: 170 mm
  • Diameter: 3 mm
  • Usable Length: 90 cm
389776

  • Peripheral angioplasty balloon catheter, basic

Passeo-35 - 07640130435735

No Description
Biotronik AG
3/150/90
Not in Commercial Distribution

  • 07640130435735 ()

  • Length: 150 mm
  • Diameter: 3 mm
  • Usable Length: 90 cm
389775

  • Peripheral angioplasty balloon catheter, basic

Passeo-35 - 07640130435704

No Description
Biotronik AG
3/200/130
Not in Commercial Distribution

  • 07640130435704 ()

  • Usable Length: 130 cm
  • Length: 200 mm
  • Diameter: 3 mm
387163

  • Peripheral angioplasty balloon catheter, basic

Passeo-35 - 07640130435698

No Description
Biotronik AG
3/200/90
Not in Commercial Distribution

  • 07640130435698 ()

  • Usable Length: 90 cm
  • Diameter: 3 mm
  • Length: 200 mm
387162

  • Peripheral angioplasty balloon catheter, basic

Passeo-35 - 07640130434745

No Description
Biotronik AG
7/200/130
Not in Commercial Distribution

  • 07640130434745 ()

  • Usable Length: 130 cm
  • Length: 200 mm
  • Diameter: 7 mm
383292

  • Peripheral angioplasty balloon catheter, basic

Passeo-35 - 07640130434738

No Description
Biotronik AG
6/200/130
Not in Commercial Distribution

  • 07640130434738 ()

  • Length: 200 mm
  • Usable Length: 130 cm
  • Diameter: 6 mm
383291

  • Peripheral angioplasty balloon catheter, basic

Passeo-35 - 07640130434721

No Description
Biotronik AG
5/200/130
Not in Commercial Distribution

  • 07640130434721 ()

  • Length: 200 mm
  • Diameter: 5 mm
  • Usable Length: 130 cm
383290

  • Peripheral angioplasty balloon catheter, basic

Passeo-35 - 07640130434714

No Description
Biotronik AG
4/200/130
Not in Commercial Distribution

  • 07640130434714 ()

  • Usable Length: 130 cm
  • Diameter: 4 mm
  • Length: 200 mm
383289

  • Peripheral angioplasty balloon catheter, basic

Passeo-35 - 07640130434707

No Description
Biotronik AG
7/170/130
Not in Commercial Distribution

  • 07640130434707 ()

  • Usable Length: 130 cm
  • Length: 170 mm
  • Diameter: 7 mm
383288

  • Peripheral angioplasty balloon catheter, basic

Passeo-35 - 07640130434691

No Description
Biotronik AG
6/170/130
Not in Commercial Distribution

  • 07640130434691 ()

  • Length: 170 mm
  • Diameter: 6 mm
  • Usable Length: 130 cm
383287

  • Peripheral angioplasty balloon catheter, basic

Passeo-35 - 07640130434684

No Description
Biotronik AG
5/170/130
Not in Commercial Distribution

  • 07640130434684 ()

  • Length: 170 mm
  • Diameter: 5 mm
  • Usable Length: 130 cm
383286

  • Peripheral angioplasty balloon catheter, basic

Passeo-35 - 07640130434677

No Description
Biotronik AG
4/170/130
Not in Commercial Distribution

  • 07640130434677 ()

  • Length: 170 mm
  • Usable Length: 130 cm
  • Diameter: 4 mm
383285

  • Peripheral angioplasty balloon catheter, basic

Passeo-35 - 07640130434660

No Description
Biotronik AG
7/150/130
Not in Commercial Distribution

  • 07640130434660 ()

  • Diameter: 7 mm
  • Usable Length: 130 cm
  • Length: 150 mm
383284

  • Peripheral angioplasty balloon catheter, basic

Passeo-35 - 07640130434653

No Description
Biotronik AG
6/150/130
Not in Commercial Distribution

  • 07640130434653 ()

  • Diameter: 6 mm
  • Usable Length: 130 cm
  • Length: 150 mm
383283

  • Peripheral angioplasty balloon catheter, basic

Passeo-35 - 07640130434646

No Description
Biotronik AG
5/150/130
Not in Commercial Distribution

  • 07640130434646 ()

  • Length: 150 mm
  • Diameter: 5 mm
  • Usable Length: 130 cm
383282

  • Peripheral angioplasty balloon catheter, basic

Passeo-35 - 07640130434639

No Description
Biotronik AG
4/150/130
Not in Commercial Distribution

  • 07640130434639 ()

  • Length: 150 mm
  • Diameter: 4 mm
  • Usable Length: 130 cm
383281

  • Peripheral angioplasty balloon catheter, basic

Passeo-35 - 07640130434622

No Description
Biotronik AG
7/120/130
Not in Commercial Distribution

  • 07640130434622 ()

  • Diameter: 7 mm
  • Usable Length: 130 cm
  • Length: 120 mm
383280

  • Peripheral angioplasty balloon catheter, basic

Passeo-35 - 07640130434615

No Description
Biotronik AG
6/120/130
Not in Commercial Distribution

  • 07640130434615 ()

  • Length: 120 mm
  • Usable Length: 130 cm
  • Diameter: 6 mm
383279

  • Peripheral angioplasty balloon catheter, basic

Passeo-35 - 07640130434608

No Description
Biotronik AG
5/120/130
Not in Commercial Distribution

  • 07640130434608 ()

  • Usable Length: 130 cm
  • Diameter: 5 mm
  • Length: 120 mm
383278

  • Peripheral angioplasty balloon catheter, basic

Passeo-35 - 07640130434592

No Description
Biotronik AG
4/120/130
Not in Commercial Distribution

  • 07640130434592 ()

  • Length: 120 mm
  • Usable Length: 130 cm
  • Diameter: 4 mm
383277

  • Peripheral angioplasty balloon catheter, basic

Passeo-35 - 07640130434585

No Description
Biotronik AG
3/120/130
Not in Commercial Distribution

  • 07640130434585 ()

  • Length: 120 mm
  • Usable Length: 130 cm
  • Diameter: 3 mm
383276

  • Peripheral angioplasty balloon catheter, basic

Passeo-35 - 07640130434554

No Description
Biotronik AG
4/100/130
Not in Commercial Distribution

  • 07640130434554 ()

  • Usable Length: 130 cm
  • Diameter: 4 mm
  • Length: 100 mm
383273

  • Peripheral angioplasty balloon catheter, basic

Passeo-35 - 07640130434547

No Description
Biotronik AG
3/100/130
Not in Commercial Distribution

  • 07640130434547 ()

  • Usable Length: 130 cm
  • Diameter: 3 mm
  • Length: 100 mm
383272

  • Peripheral angioplasty balloon catheter, basic

Passeo-35 - 07640130434530

No Description
Biotronik AG
10/80/130
Not in Commercial Distribution

  • 07640130434530 ()

  • Diameter: 10 mm
  • Usable Length: 130 cm
  • Length: 80 mm
383271

  • Peripheral angioplasty balloon catheter, basic

Passeo-35 - 07640130434523

No Description
Biotronik AG
9/80/130
Not in Commercial Distribution

  • 07640130434523 ()

  • Usable Length: 130 cm
  • Diameter: 9 mm
  • Length: 80 mm
383270

  • Peripheral angioplasty balloon catheter, basic

Passeo-35 - 07640130434516

No Description
Biotronik AG
4/80/130
Not in Commercial Distribution

  • 07640130434516 ()

  • Usable Length: 130 cm
  • Diameter: 4 mm
  • Length: 80 mm
383269

  • Peripheral angioplasty balloon catheter, basic

Passeo-35 - 07640130434509

No Description
Biotronik AG
3/80/130
Not in Commercial Distribution

  • 07640130434509 ()

  • Diameter: 3 mm
  • Length: 80 mm
  • Usable Length: 130 cm
383268

  • Peripheral angioplasty balloon catheter, basic

Passeo-35 - 07640130434493

No Description
Biotronik AG
10/60/130
Not in Commercial Distribution

  • 07640130434493 ()

  • Diameter: 10 mm
  • Usable Length: 130 cm
  • Length: 60 mm
383267

  • Peripheral angioplasty balloon catheter, basic

Passeo-35 - 07640130434486

No Description
Biotronik AG
9/60/130
Not in Commercial Distribution

  • 07640130434486 ()

  • Diameter: 9 mm
  • Usable Length: 130 cm
  • Length: 60 mm
383266

  • Peripheral angioplasty balloon catheter, basic

Passeo-35 - 07640130434479

No Description
Biotronik AG
4/60/130
Not in Commercial Distribution

  • 07640130434479 ()

  • Diameter: 4 mm
  • Usable Length: 130 cm
  • Length: 60 mm
383265

  • Peripheral angioplasty balloon catheter, basic

Passeo-35 - 07640130434462

No Description
Biotronik AG
3/60/130
Not in Commercial Distribution

  • 07640130434462 ()

  • Usable Length: 130 cm
  • Length: 60 mm
  • Diameter: 3 mm
383264

  • Peripheral angioplasty balloon catheter, basic

Passeo-35 - 07640130434455

No Description
Biotronik AG
10/40/130
Not in Commercial Distribution

  • 07640130434455 ()

  • Length: 40 mm
  • Diameter: 10 mm
  • Usable Length: 130 cm
383263

  • Peripheral angioplasty balloon catheter, basic
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