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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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Diamondback Peripheral - 10852528005855

Diamondback Peripheral, Exchangeable Series, 1.25 Micro, 75 cm shaft
Cardiovascular Systems, Inc.
DBP-EX-125MIC75
In Commercial Distribution

  • 10852528005855 ()

  • Intro Sheath: 4 Fr
  • Max OD: 0.052 inches
  • Crown Type: Micro
  • High Speed: 140 krpm
  • Medium Speed: 90 krpm
  • Low Speed: 60 krpm
  • Guidewire: 0.014 inches
  • Shaft Length: 75 cm
  • Nose Length: 7 mm
  • Crown Diameter: 1.25 mm
7-10030-05

  • Mechanical atherectomy system catheter, peripheral

Diamondback Peripheral - 10852528005831

Diamondback Peripheral, Exchangeable Series, 1.50 Solid, 145 cm shaft
Cardiovascular Systems, Inc.
DBP-EX-150SOL145
In Commercial Distribution

  • 10852528005831 ()

  • Intro Sheath: 5 Fr
  • Max OD: 0.063 inches
  • Crown Type: Solid
  • High Speed: 120 krpm
  • Medium Speed: 90 krpm
  • Low Speed: 60 krpm
  • Guidewire: 0.014 inches
  • Shaft Length: 145 cm
  • Nose Length: 10 mm
  • Crown Diameter: 1.50 mm
7-10030-03

  • Mechanical atherectomy system catheter, peripheral

Extended Length ViperWire Advance - 10852528005732

ViperWire, Advance, , Flex Tip, Extended Length, Peripheral, 0.014" Dia spring tip, 475cm, 5 Pack
Cardiovascular Systems, Inc.
VPR-GW-ELFLEX14
In Commercial Distribution

  • 30852528005736 ()
  • 10852528005732 ()

  • Max Tip Diameter 0.014 inches
7-10041-01

  • Peripheral vascular guidewire, manual

ViperWire Advance FlexTip - 10852528005718

VIPERWIRE, ADVANCE FLEXTIP PERIPHERAL, .014" DIA SPRING TIP, 335CM, 5 PACK
Cardiovascular Systems, Inc.
VPR-GW-FLEX14
In Commercial Distribution

  • 10852528005718 ()
  • 30852528005712 ()

  • Max Tip Diameter 0.014 inches
7-10041-03

  • Peripheral vascular guidewire, manual

Diamondback Coronary - 10852528005701

Guidewire, Viperwire Advance Coronary Flex Tip .014: dia, .012" 1 Pack 325 cm
Cardiovascular Systems, Inc.
GWC-12325LG-FT
In Commercial Distribution

  • 30852528005705 ()
  • 10852528005701 ()

  • Length 325 cm
  • Max Shaft Diameter 0.012 inches
  • Max Tip Diameter: 0.014 inches
7-10038-01

  • Cardiac/peripheral vascular guidewire, single-use

ViperCath XC - 10852528005688

200 cm, 0.035" guidewire compatible, support catheter
Cardiovascular Systems, Inc.
035-XC-200-0
In Commercial Distribution

  • 10852528005688 ()

  • Max Outer Diameter: 0.059 inches
  • Inner Diameter: 0.035 inches
  • Length: 200 cm
7-10043-01

  • Vascular guide-catheter, single-use

ZILIENT - 10852528005626

4gram tip, short taper, .014" diameter 300cm
Cardiovascular Systems, Inc.
04G-300-014
Not in Commercial Distribution

  • 10852528005626 ()
  • 30852528005620 ()

  • Max Tip Diameter: 0.014 inches; Tip Support: 4 grams; Length: 300cm
7-10049-02

  • Peripheral vascular guidewire, manual

ZILIENT - 10852528005619

4gram tip, short taper, .014" diameter 195cm
Cardiovascular Systems, Inc.
04G-195-014
Not in Commercial Distribution

  • 30852528005613 ()
  • 10852528005619 ()

  • Max Tip Diameter: 0.014 inches; Tip Support: 4 grams; Length: 195cm
7-10049-01

  • Peripheral vascular guidewire, manual

ZILIENT - 10852528005602

30gram tip, short taper, .018" diameter 300cm
Cardiovascular Systems, Inc.
30G-300-018
Not in Commercial Distribution

  • 30852528005606 ()
  • 10852528005602 ()

  • Max Tip Diameter: 0.018 inches; Tip Support: 30 grams; Length: 300cm
7-10050-08

  • Peripheral vascular guidewire, manual

ZILIENT - 10852528005596

30gram tip, short taper, .018" diameter 195cm
Cardiovascular Systems, Inc.
30G-195-018
Not in Commercial Distribution

  • 30852528005590 ()
  • 10852528005596 ()

  • Max Tip Diameter: 0.018 inches; Tip Support: 30 grams; Length: 195cm
7-10050-07

  • Peripheral vascular guidewire, manual

ZILIENT - 10852528005589

30gram tip, short taper, .014" diameter 300cm
Cardiovascular Systems, Inc.
30G-300-014
Not in Commercial Distribution

  • 30852528005583 ()
  • 10852528005589 ()

  • Max Tip Diameter: 0.014 inches; Tip Support: 30 grams; Length: 300cm
7-10050-06

  • Peripheral vascular guidewire, manual

ZILIENT - 10852528005572

30gram tip, short taper, .014" diameter 195cm
Cardiovascular Systems, Inc.
30G-195-014
Not in Commercial Distribution

  • 30852528005576 ()
  • 10852528005572 ()

  • Max Tip Diameter: 0.014 inches; Tip Support: 30 grams; Length: 195cm
7-10050-05

  • Peripheral vascular guidewire, manual

ZILIENT - 10852528005565

12gram tip, long taper, .018" diameter 300cm
Cardiovascular Systems, Inc.
12G-300-018
Not in Commercial Distribution

  • 30852528005569 ()
  • 10852528005565 ()

  • Max Tip Diameter: 0.018 inches; Tip Support: 12 grams; Length: 300cm
7-10050-04

  • Peripheral vascular guidewire, manual

ZILIENT - 10852528005558

12gram tip, long taper, .018" diameter 195cm
Cardiovascular Systems, Inc.
12G-195-018
Not in Commercial Distribution

  • 30852528005552 ()
  • 10852528005558 ()

  • Max Tip Diameter: 0.018 inches; Tip Support: 12 grams; Length: 195cm
7-10050-03

  • Peripheral vascular guidewire, manual

ZILIENT - 10852528005541

12gram tip, long taper, .014" diameter 300cm
Cardiovascular Systems, Inc.
12G-300-014
Not in Commercial Distribution

  • 30852528005545 ()
  • 10852528005541 ()

  • Max Tip Diameter: 0.014 inches; Tip Support: 12 grams; Length: 300cm
7-10050-02

  • Peripheral vascular guidewire, manual

ZILIENT - 10852528005534

12 gram tip, long taper, .014" diameter 195cm
Cardiovascular Systems, Inc.
12G-195-014
Not in Commercial Distribution

  • 30852528005538 ()
  • 10852528005534 ()

  • Max Tip Diameter: 0.014 inches; Tip Support: 12 grams; Length: 195cm
7-10050-01

  • Peripheral vascular guidewire, manual

ZILIENT - 10852528005527

6 gram tip, long taper, .018" diameter 300cm
Cardiovascular Systems, Inc.
06G-300-018
Not in Commercial Distribution

  • 30852528005521 ()
  • 10852528005527 ()

  • Max Tip Diameter: 0.018 inches; Tip Support: 6 grams; Length: 300cm
7-10049-08

  • Peripheral vascular guidewire, manual

ZILIENT - 10852528005510

6gram tip, long taper, .018" diameter 195cm
Cardiovascular Systems, Inc.
06G-195-018
Not in Commercial Distribution

  • 30852528005514 ()
  • 10852528005510 ()

  • Max Tip Diameter: 0.018 inches; Tip Support: 6 grams; Length: 195cm
7-10049-07

  • Peripheral vascular guidewire, manual

ZILIENT - 10852528005503

6gram tip, long taper, .014" diameter 300cm
Cardiovascular Systems, Inc.
06G-300-014
Not in Commercial Distribution

  • 30852528005507 ()
  • 10852528005503 ()

  • Max Tip Diameter: 0.014 inches; Tip Support: 6 grams; Length: 300cm
7-10049-06

  • Peripheral vascular guidewire, manual

ZILIENT - 10852528005497

6gram tip, long taper, .014" diameter 195cm
Cardiovascular Systems, Inc.
06G-195-014
Not in Commercial Distribution

  • 30852528005491 ()
  • 10852528005497 ()

  • Max Tip Diameter: 0.014 inches; Tip Support: 6 grams; Length: 195cm
7-10049-05

  • Peripheral vascular guidewire, manual

ZILIENT - 10852528005480

4gram tip, short taper, .018" diameter 300cm
Cardiovascular Systems, Inc.
04G-300-018
Not in Commercial Distribution

  • 30852528005484 ()
  • 10852528005480 ()

  • Max Tip Diameter: 0.018 inches; Tip Support: 4 grams; Length: 300cm
7-10049-04

  • Peripheral vascular guidewire, manual

ZILIENT - 10852528005473

4gram tip, short taper, .018" diameter 195cm
Cardiovascular Systems, Inc.
04G-195-018
Not in Commercial Distribution

  • 10852528005473 ()
  • 30852528005477 ()

  • Max Tip Diameter: 0.018 inches; Tip Support: 4 grams; Length: 195cm
7-10049-03

  • Peripheral vascular guidewire, manual

Extended Length ViperWire Advance - 10852528005466

ViperWire, Advance, Extended Length, Peripheral, 0.018" Dia spring tip, 475cm, 5 Pack
Cardiovascular Systems, Inc.
VPR-GW-EL18
In Commercial Distribution

  • 10852528005466 ()
  • 30852528005460 ()

  • Length: 475 Centimeter
  • Shaft Diameter 0.014 inches
  • Max Tip Diameter 0.018 inches
7-10035-02

  • Peripheral vascular guidewire, manual

Extended Length ViperWire Advance - 10852528005459

ViperWire, Advance, Extended Length, Peripheral, 0.014" Dia spring tip, 475cm, 5 Pack
Cardiovascular Systems, Inc.
VPR-GW-EL14
In Commercial Distribution

  • 30852528005453 ()
  • 10852528005459 ()

  • Length: 475 Centimeter
  • Shaft Diameter 0.014 inches
  • Max Tip Diameter 0.014 inches
7-10035-01

  • Peripheral vascular guidewire, manual

Diamondback Coronary - 10852528005442

SALINE INFUSION PUMP (SIP)
Cardiovascular Systems, Inc.
SIP-3000
In Commercial Distribution

  • 10852528005442 ()
7-10037-01

  • Atherectomy system saline/lubricant pump

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

Airo™ CPAP Mask Liners - 00850054813381

Airo™ CPAP Mask Liners - Box of 25 - Large
Athfar 828 Inc
AL-25
In Commercial Distribution

  • 00850054813343 ()
  • 00850054813381 ()


  • General-purpose medical fibre padding

Airo™ CPAP Mask Liners - 00850054813374

Airo™ CPAP Mask Liners - Box of 25 - Small
Athfar 828 Inc
AS-25
In Commercial Distribution

  • 00850054813350 ()
  • 00850054813374 ()


  • General-purpose medical fibre padding

Airo™ CPAP Mask Liners - 00850054813367

Airo™ CPAP Mask Liners - Box of 25 - Medium
Athfar 828 Inc
AM-25
In Commercial Distribution

  • 00850054813336 ()
  • 00850054813367 ()


  • General-purpose medical fibre padding

Airo™ CPAP Mask Liners - 00850054813329

Evaluation Pack - Airo™ CPAP Mask Liners - Box of 50 - Large
Athfar 828 Inc
EVAL-AL-50
In Commercial Distribution

  • 00850054813299 ()
  • 00850054813329 ()
EVAL-AL-50

  • General-purpose medical fibre padding

Airo™ CPAP Mask Liners - 00850054813084

Airo™ CPAP Mask Liners - Box of 100 - Small
Athfar 828 Inc
AS-100
In Commercial Distribution

  • 00850054813350 ()
  • 00850054813084 ()


  • General-purpose medical fibre padding

Airo™ CPAP Mask Liners - 00850054813077

Airo™ CPAP Mask Liners - Box of 100 - Medium
Athfar 828 Inc
AM-100
In Commercial Distribution

  • 00850054813336 ()
  • 00850054813077 ()


  • General-purpose medical fibre padding

Airo™ CPAP Mask Liners - 00850054813060

Airo™ CPAP Mask Liners - Box of 100 - Large
Athfar 828 Inc
AL-100
In Commercial Distribution

  • 00850054813343 ()
  • 00850054813060 ()


  • General-purpose medical fibre padding

Airo™ CPAP Mask Liners - 00850054813053

Airo™ CPAP Mask Liners - Box of 50 - Small
Athfar 828 Inc
AS-50
In Commercial Distribution

  • 00850054813350 ()
  • 00850054813053 ()


  • General-purpose medical fibre padding

Airo™ CPAP Mask Liners - 00850054813046

Airo™ CPAP Mask Liners - Box of 50 - Medium
Athfar 828 Inc
AM-50
In Commercial Distribution

  • 00850054813336 ()
  • 00850054813046 ()


  • General-purpose medical fibre padding

Airo™ CPAP Mask Liners - 00850054813022

Airo™ CPAP Mask Liners - Box of 50 - Large
Athfar 828 Inc
AL-50
In Commercial Distribution

  • 00850054813343 ()
  • 00850054813022 ()


  • General-purpose medical fibre padding

Airo™ CPAP Mask Liners - 00850054813008

Airo™ CPAP Mask Liners - Box of 25 - Small
Athfar 828 Inc
AS-25
Not in Commercial Distribution

  • 00850054813121 ()
  • 00850054813008 ()
AS-25

  • General-purpose medical fibre padding

OPELAIII Attached Belt (3L) - 14589864500350

Wearable Surgical Lighting System
TAIYO CORPORATION
-H
In Commercial Distribution

  • 14589864500350 ()


  • Head-worn lamp

OPELAIII COOLMAX® Comfort Inner Pads - 14589864500336

Wearable Surgical Lighting System
TAIYO CORPORATION
-H
In Commercial Distribution

  • 14589864500336 ()


  • Head-worn lamp

OPELAIII calibration kit - 14589864500312

Wearable Surgical Lighting System
TAIYO CORPORATION
-H
In Commercial Distribution

  • 14589864500312 ()


  • Head-worn lamp

OPELAIII Protected Special Package - 14589864500282

Wearable Surgical Lighting System
TAIYO CORPORATION
-H
In Commercial Distribution

  • 14589864500282 ()


  • Head-worn lamp

OPELAIII Protected Special Package - 14589864500275

Wearable Surgical Lighting System
TAIYO CORPORATION
-H
In Commercial Distribution

  • 14589864500275 ()


  • Head-worn lamp

OPELAIII Hard Case - 14589864500237

Wearable Surgical Lighting System
TAIYO CORPORATION
-H
In Commercial Distribution

  • 14589864500237 ()


  • Head-worn lamp

OPELAIII Cord Clip (Large) - 14589864500213

Wearable Surgical Lighting System
TAIYO CORPORATION
-H
In Commercial Distribution

  • 14589864500213 ()


  • Head-worn lamp

OPELAIII Cord Clip (Small) - 14589864500206

Wearable Surgical Lighting System
TAIYO CORPORATION
-H
In Commercial Distribution

  • 14589864500206 ()


  • Head-worn lamp

OPELAIII Antibacterial Urethane Pad - 14589864500176

Wearable Surgical Lighting System
TAIYO CORPORATION
-H
Not in Commercial Distribution

  • 14589864500176 ()


  • Head-worn lamp

OPELAIII Storage Bag (with calibration kit) - 14589864500169

Wearable Surgical Lighting System
TAIYO CORPORATION
-H
In Commercial Distribution

  • 14589864500169 ()


  • Head-worn lamp

OPELAIII Attached Belt (LL) - 14589864500152

Wearable Surgical Lighting System
TAIYO CORPORATION
-H
In Commercial Distribution

  • 14589864500152 ()


  • Head-worn lamp

OPELAIII Attached Belt (M-L) - 14589864500145

Wearable Surgical Lighting System
TAIYO CORPORATION
-H
In Commercial Distribution

  • 14589864500145 ()


  • Head-worn lamp

OPELAIII Dedicated AC Adapter - 14589864500138

Wearable Surgical Lighting System
TAIYO CORPORATION
-H
In Commercial Distribution

  • 14589864500138 ()


  • Head-worn lamp
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