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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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ViperCross - 10850026568179

ViperCross Support Catheter, 018", 150cm, Straight
Cardiovascular Systems, Inc.
P1VC-018STR-150
Not in Commercial Distribution

  • 10850026568179 ()

  • Guidewire Compatability: 0.018 Inches
  • Shaft Diameter: 0.0375 Inches
  • Length: 150cm
  • Tip Shape: Straight
7-10093-04

  • Vascular microcatheter

ViperCross - 10850026568162

ViperCross Support Catheter, 018", 135cm, Straight
Cardiovascular Systems, Inc.
P1VC-018STR-135
Not in Commercial Distribution

  • 10850026568162 ()

  • Guidewire Compatability: 0.018 Inches
  • Shaft Diameter: 0.0375 Inches
  • Length: 135cm
  • Tip Shape: Straight
7-10093-03

  • Vascular microcatheter

ViperCross - 10850026568155

ViperCross Support Catheter, 018", 90cm, Straight
Cardiovascular Systems, Inc.
P1VC-018STR-090
Not in Commercial Distribution

  • 10850026568155 ()

  • Guidewire Compability: 0.018 Inches
  • Shaft Diameter: 0.0375 Inches
  • Length: 90cm
  • Tip Shape: Straight
7-10093-02

  • Vascular microcatheter

ViperCross - 10850026568148

ViperCross Support Catheter, 018", 65cm Straight
Cardiovascular Systems, Inc.
P1VC-018STR-065
Not in Commercial Distribution

  • 10850026568148 ()

  • Guidewire Compatability: 0.018 Inches
  • Shaft Diameter: 0.0375 Inches
  • Length: 65cm
  • Tip Shape: Straight
7-10093-01

  • Vascular microcatheter

ViperCross - 10850026568131

ViperCross Support Catheter, 014", 150cm, Straight
Cardiovascular Systems, Inc.
P1VC-014STR-150
Not in Commercial Distribution

  • 10850026568131 ()

  • Guidewire Compability: 0.014 Inches
  • Shaft Diameter: 0.0375 Inches
  • Length: 150cm
  • Tip Shape: Straight
7-10092-02

  • Vascular microcatheter

ViperCross - 10850026568124

ViperCross Support Catheter, 014", 135cm, Straight
Cardiovascular Systems, Inc.
P1VC-014STR-135
Not in Commercial Distribution

  • 10850026568124 ()

  • Guidewire Compatability: 0.014 Inches
  • Shaft Diameter: 0.0375 Inches
  • Length: 135cm
  • Tip Shape: Straight
7-10092-01

  • Vascular microcatheter

Diamondback Coronary - 10850026568100

DIAMONDBACK CORONARY, CLASSIC CROWN, 1.25MM, 135CM SHAFT
Cardiovascular Systems, Inc.
DBEC-125
In Commercial Distribution

  • 10850026568100 ()

  • Crown diameter, 1.25mm
  • Nose Length, 5mm
  • Shaft Length, 135cm
  • Guidewire Size OD, 0.012 inches
  • Low Speed, 80 krpm
  • Medium Speed, krpm
  • High Speed, 120 krpm
  • Crown Type, Classic
  • Max OD, 0.0495
  • Intro Sheath, 6
7-10060-10

  • Mechanical atherectomy system, coronary, line-powered

Diamondback Coronary - 10850026568087

DIAMONDBACK CORONARY, CLASSIC CROWN, 1.25MM, 135CM SHAFT
Cardiovascular Systems, Inc.
DBEC-125
In Commercial Distribution

  • 10850026568087 ()

  • Crown diameter, 1.25mm
  • Nose Length, 5mm
  • Shaft length, 135cm
  • Guidewire size OD, 0.012 inches
  • Low Speed, 80 krpm
  • Medium Speed, krpm
  • High Speed, 120 krpm
  • Crown Type, Classic
  • Max OD, 0.0495 inches
  • Intro Sheath, 6Fr
7-10060-09

  • Mechanical atherectomy system, coronary, line-powered

Shepherd - 10850026568537

0.014" Shepherd ES Guidewire - straight 195 cm - 4 gms
Cardiovascular Systems, Inc.
PSP14S-19504
In Commercial Distribution

  • 30850026568531 ()
  • 10850026568537 ()

  • Guidewire Diameter: 0.014 Inch
  • Length: 195 Inch
  • Hydrophilic Coating
  • Tip Flex 4 Grams
  • Tip Shape Straight
  • Tip Design Polymer Jacket
7-10096-01

  • Peripheral vascular guidewire, manual

Diamondback Coronary - 10850026568698

DIAMONDBACK CORONARY, CLASSIC CROWN, 1.25MM, 135CM SHAFT
Cardiovascular Systems, Inc.
DBEC-125
In Commercial Distribution

  • 10850026568698 ()

  • Low Speed 80krpm
  • Medium Speed krpm
  • High Speed 120krpm
  • Crown Type Classic
  • Max OD 0.0495in
  • Intro Sheath 6Fr
  • Crown Diameter 1.25mm
  • Nose Length 5mm
  • Shaft Length: 135 Centimeter
  • Guidewire Size OD 0.012in
7-10098-01

  • Mechanical atherectomy system, coronary, line-powered

FJ Clip 5 - 00883475951660

No Description
CHARMANT INC.
24-0001
In Commercial Distribution

  • 00883475951660 ()


  • Gastrointestinal endoscopic clip applier

SleepmateThermistor - Alice 5 - 05707480042180

Alice 5 Thermistor
Ambu A/S
814910-121
In Commercial Distribution

  • 05707480042180 ()
814910-121

  • Polysomnograph

SleepmateCannuTherm, - Alice 5 - 05707480042043

Ref. 1464
Ambu A/S
814310-121
Not in Commercial Distribution

  • 05707480042043 ()
814310-121

  • Polysomnograph

Surround 5.x - 00860007282737

Surround 5.x
Gpi Usa, Inc.
5.x
In Commercial Distribution



  • Blood bank information system

FleXNeedle (5 pack) - 00856571007210

Single use coring needle for retrieval of tissue samples. It is placed through a flexible bronchoscope.
BRONCUS MEDICAL INC.
10005-2
In Commercial Distribution

  • 00856571007210 ()

  • Needle Gauge: 18 Gauge
10005-2

  • Soft-tissue biopsy needle, single-use

AirSep FreeStyle 5 - M766AS077101CU0

AirSep FreeStyle 5 Portable Oxygen Concentrator, 1-5LPM, External Battery, Re-Manufactured
CAIRE INC.
AS077-101CU
In Commercial Distribution

  • M766AS077101CU0 ()


  • Mobile/portable oxygen concentrator

Cytokeratin 5 (CK5) - 00847627041340

No Description
BIOCARE MEDICAL LLC
NPAI234T40
In Commercial Distribution

  • 00847627041340 ()


  • Cytokeratin IVD, antibody

SurgiView Direct .5 - 00850054345349

No Description
Ion Vision, Inc
P-IOV-047
In Commercial Distribution

  • 00850054345349 ()


  • Surgical camera lens

Fusion Bond 5 - D96710004

No Description
PREVEST DENPRO LIMITED
Economy Pack
In Commercial Distribution

  • D96710004 ()
10004

  • Dental acrylic resin kit

Fusion Bond 5 - D96710003

No Description
PREVEST DENPRO LIMITED
Intro Pack
In Commercial Distribution

  • D96710003 ()
10003

  • Dental acrylic resin kit
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