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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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ViperWire Advance FlexTip - 10852528005312

VIPERWIRE, ADVANCE FLEXTIP PERIPHERAL, .018" DIA SPRING TIP, 335CM, 5 PACK
Cardiovascular Systems, Inc.
VPR-GW-FT14
In Commercial Distribution

  • 30852528005316 ()
  • 10852528005312 ()

  • Length: 335 Centimeter
  • Shaft Diameter 0.014 inches
  • Max Tip Diameter 0.014 inches
7-10026-01

  • Peripheral vascular guidewire, manual

Diamondback Peripheral - 10852528005282

DIAMONDBACK PERIPHERAL, MICRO CROWN, 1.25MM, 145CM SHAFT
Cardiovascular Systems, Inc.
DBP-125MICRO145
In Commercial Distribution

  • 10852528005282 ()

  • Crown Type, Micro
  • Intro Sheath 4 Fr
  • Max OD 0.052 inches
  • high speed 140 krmp
  • medium speed 90 krpm
  • low speed 60 krpm
  • Guidewirre 0.014 inches
  • shaft lengh 145 cm
  • nose lengh 7 mm
  • Crown diameter 1.25 mm
7-10024

  • Mechanical atherectomy system catheter, peripheral

Diamondback Peripheral - 10852528005268

DIAMONDBACK PERIPHERAL, CLASSIC CROWN, 2.00MM, 145CM SHAFT
Cardiovascular Systems, Inc.
DBP–200CLASS145
In Commercial Distribution

  • 10852528005268 ()

  • Crown Type, Classic
  • Intro Sheath 6 Fr
  • Max OD 0.079 inches
  • high speed 140 krpm
  • medium speed 90 krpm
  • low speed 60 krpm
  • guidewire size OD 0.014 inches
  • shaft length 145 cm
  • nose length 20 mm
  • Crown Diameter 2.00 mm
7-10017

  • Mechanical atherectomy system catheter, peripheral

Diamondback Peripheral - 10852528005251

DIAMONDBACK PERIPHERAL, CLASSIC CROWN, 1.50MM, 145CM SHAFT
Cardiovascular Systems, Inc.
DBP–150CLASS145
In Commercial Distribution

  • 10852528005251 ()

  • Crown Type, Classic
  • Intro Sheath 5 Fr
  • Max OD 0.063 inches
  • high speed 140 krpm
  • medium speed 90 krpm
  • Low Speed 60 krpm
  • Guidewire Size OD 0.014 inches
  • shaft length 145 cm
  • Nose Length 15 mm
  • Crown Diameter 1.50 mm
7-10016

  • Mechanical atherectomy system catheter, peripheral

Diamondback Peripheral - 10852528005244

DIAMONDBACK PERIPHERAL, SOLID CROWN, 1.25MM, 145CM SHAFT
Cardiovascular Systems, Inc.
DBP-125SOLID145
In Commercial Distribution

  • 10852528005244 ()

  • Crown Type, Solid
  • Intro Sheath 4 Fr
  • Max OD 0.052 inches
  • High Speed 120 krpm
  • Medium Speed 90 krpm
  • Low Speed 60 krpm
  • Guidewire size OD 0.014 inches
  • Shaft Length 145 cm
  • Nose Length 7 mm
  • Crown Diameter 1.25 mm
7-10012

  • Mechanical atherectomy system catheter, peripheral

Diamondback Peripheral - 10852528005237

DIAMONDBACK PERIPHERAL, SOLID CROWN, 1.50MM, 145CM SHAFT
Cardiovascular Systems, Inc.
DBP-150SOLID145
In Commercial Distribution

  • 10852528005237 ()

  • Crown Type, Solid
  • Intro Sheath 5 Fr
  • Max OD 0.063 inches
  • High Speed 120 krpm
  • Medium Speed 90 krpm
  • Low Speed 60 krpm
  • Guidewire Size OD 0.014 inches
  • Shaft Length 145 cm
  • Nose Length 10 mm
  • Crown Diameter 1.50 mm
7-10011

  • Mechanical atherectomy system catheter, peripheral

ViperWire - 10852528005220

VIPERWIRE, ADVANCED, .012" DIA .012" SPRING TIP, 200CM, 5 PACK
Cardiovascular Systems, Inc.
VPR-GW-200
In Commercial Distribution

  • 30852528005224 ()
  • 10852528005220 ()

  • Length: 200 Centimeter
  • Max Shaft Diameter 0.012 inches
  • Max Tip Diameter 0.014 inches
7-10004

  • Peripheral vascular guidewire, manual

Diamondback Peripheral - 10852528005213

DIAMONDBACK PERIPHERAL, SOLID CROWN, 1.25MM, 60CM SHAFT
Cardiovascular Systems, Inc.
DBP-125SOLID60
In Commercial Distribution

  • 10852528005213 ()

  • Intro Sheath 4 Fr
  • Max OD 0.053 inches
  • High Speed 140 krpm
  • Medium Speed 90 krpm
  • low speed 60 krpm
  • guidewire size OD 0.012 inches
  • Shaft Length 60 cm
  • Nose Length 10 mm
  • Crown Diameter 1.25 mm
  • Crown Type, Solid
7-10002

  • Mechanical atherectomy system catheter, peripheral

Diamondback Peripheral - 10852528005206

DIAMONDBACK PERIPHERAL, MICRO CROWN, 1.25MM, 60CM SHAFT
Cardiovascular Systems, Inc.
DBP-125MICRO60
In Commercial Distribution

  • 10852528005206 ()

  • Intro Sheath 4 Fr
  • Max OD 0.053 inches
  • High Speed 140 krpm
  • Medium Speed 90 krpm
  • Low Speed 60 krpm
  • guidewire size OD 0.012 inches
  • Shaft Length 60 cm
  • Nose Length 7 mm
  • Crown Size 1.25 mm
  • Crown Type, Micro
7-10001

  • Mechanical atherectomy system catheter, peripheral

COM module for use with the MAC 5500 ST electrocardiograph - 04059358001470

No Description
ergoline GmbH
705780
In Commercial Distribution

  • 04059358001470 ()


  • Bicycle ergometer

VADER Pedicle System, VADER Pedicle System Navigated Instruments, Container, com - 07640172552438

VADER Pedicle System, VADER Pedicle System Navigated Instruments, Container, complete
icotec AG
42-700
In Commercial Distribution

  • 07640172552438 ()
42-700

  • Device sterilization/disinfection container, reusable

AmeriWater Water Purification System for Hemodialysis - 00817927020338

AmeriWater Water Purification System for Hemodialysis including reverse osmosis with pre-treatment and post-treatment intended to produce water that meets all current AAMI and Federal (U.S.) standards for water used in hemodialysis.
AMERIWATER, LLC
Complete System
In Commercial Distribution

  • 00817927020338 ()


  • Reverse-osmosis water purification system

BPCO Ointment - 00371351014603

Class I (general controls), 510(k) exempt medical device with a product code of NAD. Per the Code of Federal Regulations, it is regulated under 21 CFR 878.4020 as an occlusive wound dressing.
Brookfield Pharmaceuticals, Llc
1
In Commercial Distribution

  • 00371351014603 ()


  • Skin semi-occlusive dressing, non-antimicrobial

FRYE - 00193033618301

No Description
FGX INTERNATIONAL INC.
10266424.COM
In Commercial Distribution

  • 00193033618301 ()


  • Tinted non-prescription spectacles

FRYE - 00193033618295

No Description
FGX INTERNATIONAL INC.
10266423.COM
In Commercial Distribution

  • 00193033618295 ()


  • Tinted non-prescription spectacles

FRYE - 00193033618288

No Description
FGX INTERNATIONAL INC.
10266422.COM
In Commercial Distribution

  • 00193033618288 ()


  • Tinted non-prescription spectacles

FRYE - 00193033618271

No Description
FGX INTERNATIONAL INC.
10266421.COM
In Commercial Distribution

  • 00193033618271 ()


  • Tinted non-prescription spectacles

FRYE - 00193033618264

No Description
FGX INTERNATIONAL INC.
10266420.COM
In Commercial Distribution

  • 00193033618264 ()


  • Tinted non-prescription spectacles

FRYE - 00193033618257

No Description
FGX INTERNATIONAL INC.
10266419.COM
In Commercial Distribution

  • 00193033618257 ()


  • Tinted non-prescription spectacles

FRYE - 00193033618240

No Description
FGX INTERNATIONAL INC.
10266418.COM
In Commercial Distribution

  • 00193033618240 ()


  • Tinted non-prescription spectacles

FRYE - 00193033618233

No Description
FGX INTERNATIONAL INC.
10266417.COM
In Commercial Distribution

  • 00193033618233 ()


  • Tinted non-prescription spectacles

FRYE - 00193033618226

No Description
FGX INTERNATIONAL INC.
10266416.COM
In Commercial Distribution

  • 00193033618226 ()


  • Tinted non-prescription spectacles

FRYE - 00193033618219

No Description
FGX INTERNATIONAL INC.
10266415.COM
In Commercial Distribution

  • 00193033618219 ()


  • Tinted non-prescription spectacles

FRYE - 00193033618202

No Description
FGX INTERNATIONAL INC.
10266414.COM
In Commercial Distribution

  • 00193033618202 ()


  • Tinted non-prescription spectacles

FRYE - 00193033618196

No Description
FGX INTERNATIONAL INC.
10266413.COM
In Commercial Distribution

  • 00193033618196 ()


  • Tinted non-prescription spectacles

FRYE - 00193033618189

No Description
FGX INTERNATIONAL INC.
10266412.COM
In Commercial Distribution

  • 00193033618189 ()


  • Tinted non-prescription spectacles

FRYE - 00193033618172

No Description
FGX INTERNATIONAL INC.
10266411.COM
In Commercial Distribution

  • 00193033618172 ()


  • Tinted non-prescription spectacles

FRYE - 00193033618165

No Description
FGX INTERNATIONAL INC.
10266410.COM
In Commercial Distribution

  • 00193033618165 ()


  • Tinted non-prescription spectacles

FRYE - 00193033618158

No Description
FGX INTERNATIONAL INC.
10266409.COM
In Commercial Distribution

  • 00193033618158 ()


  • Tinted non-prescription spectacles

FRYE - 00193033618141

No Description
FGX INTERNATIONAL INC.
10266408.COM
In Commercial Distribution

  • 00193033618141 ()


  • Tinted non-prescription spectacles

FRYE - 00193033618134

No Description
FGX INTERNATIONAL INC.
10266407.COM
In Commercial Distribution

  • 00193033618134 ()


  • Tinted non-prescription spectacles

FRYE - 00193033618127

No Description
FGX INTERNATIONAL INC.
10266406.COM
In Commercial Distribution

  • 00193033618127 ()


  • Tinted non-prescription spectacles

FRENCH CONNECTION - 00193033616451

No Description
FGX INTERNATIONAL INC.
10266463.COM
In Commercial Distribution

  • 00193033616451 ()


  • Tinted non-prescription spectacles

FRENCH CONNECTION - 00193033616444

No Description
FGX INTERNATIONAL INC.
10266462.COM
In Commercial Distribution

  • 00193033616444 ()


  • Tinted non-prescription spectacles

FRENCH CONNECTION - 00193033616437

No Description
FGX INTERNATIONAL INC.
10266461.COM
In Commercial Distribution

  • 00193033616437 ()


  • Tinted non-prescription spectacles

FRENCH CONNECTION - 00193033616420

No Description
FGX INTERNATIONAL INC.
10266460.COM
In Commercial Distribution

  • 00193033616420 ()


  • Tinted non-prescription spectacles

FRENCH CONNECTION - 00193033616413

No Description
FGX INTERNATIONAL INC.
10266459.COM
In Commercial Distribution

  • 00193033616413 ()


  • Tinted non-prescription spectacles

FRENCH CONNECTION - 00193033616406

No Description
FGX INTERNATIONAL INC.
10266458.COM
In Commercial Distribution

  • 00193033616406 ()


  • Tinted non-prescription spectacles

FRENCH CONNECTION - 00193033616390

No Description
FGX INTERNATIONAL INC.
10266457.COM
In Commercial Distribution

  • 00193033616390 ()


  • Tinted non-prescription spectacles

FRENCH CONNECTION - 00193033616383

No Description
FGX INTERNATIONAL INC.
10266456.COM
In Commercial Distribution

  • 00193033616383 ()


  • Tinted non-prescription spectacles
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