Diamondback Coronary 7-10038-01

GUDID 30852528005705

Guidewire, Viperwire Advance Coronary Flex Tip .014: dia, .012" 1 Pack 325 cm

Cardiovascular Systems, Inc.

Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use
Primary Device ID30852528005705
NIH Device Record Key79398385-74c2-4219-88c8-5994baa83f71
Commercial Distribution StatusIn Commercial Distribution
Brand NameDiamondback Coronary
Version Model NumberGWC-12325LG-FT
Catalog Number7-10038-01
Company DUNS024954518
Company NameCardiovascular Systems, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone877-274-0360
Emailcustomerservice@csi360.com
Phone877-274-0360
Emailcustomerservice@csi360.com
Phone877-274-0360
Emailcustomerservice@csi360.com
Phone877-274-0360
Emailcustomerservice@csi360.com
Phone877-274-0360
Emailcustomerservice@csi360.com
Phone877-274-0360
Emailcustomerservice@csi360.com
Phone877-274-0360
Emailcustomerservice@csi360.com
Phone877-274-0360
Emailcustomerservice@csi360.com
Phone877-274-0360
Emailcustomerservice@csi360.com
Phone877-274-0360
Emailcustomerservice@csi360.com
Phone877-274-0360
Emailcustomerservice@csi360.com
Phone877-274-0360
Emailcustomerservice@csi360.com
Phone877-274-0360
Emailcustomerservice@csi360.com
Phone877-274-0360
Emailcustomerservice@csi360.com
Phone877-274-0360
Emailcustomerservice@csi360.com
Phone877-274-0360
Emailcustomerservice@csi360.com
Phone877-274-0360
Emailcustomerservice@csi360.com

Device Dimensions

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Device Identifiers

Device Issuing AgencyDevice ID
GS110852528005701 [Primary]
GS130852528005705 [Package]
Contains: 10852528005701
Package: BOX [5 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MCXCatheter, Coronary, Atherectomy

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[30852528005705]

Ethylene Oxide

[30852528005705]

Ethylene Oxide

[30852528005705]

Ethylene Oxide

[30852528005705]

Ethylene Oxide

[30852528005705]

Ethylene Oxide

[30852528005705]

Ethylene Oxide

[30852528005705]

Ethylene Oxide

[30852528005705]

Ethylene Oxide

[30852528005705]

Ethylene Oxide

[30852528005705]

Ethylene Oxide

[30852528005705]

Ethylene Oxide

[30852528005705]

Ethylene Oxide

[30852528005705]

Ethylene Oxide

[30852528005705]

Ethylene Oxide

[30852528005705]

Ethylene Oxide

[30852528005705]

Ethylene Oxide

[30852528005705]

Ethylene Oxide

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-10-01
Device Publish Date2019-09-23

On-Brand Devices [Diamondback Coronary]

30852528005705Guidewire, Viperwire Advance Coronary Flex Tip .014: dia, .012" 1 Pack 325 cm
10850000491363DIAMONDBACK CORONARY, CLASSIC CROWN, 1.25MM, 135CM SHAFT
10850000491356DIAMONDBACK CORONARY, CLASSIC CROWN, 1.25MM, 135CM SHAFT
10850026568100DIAMONDBACK CORONARY, CLASSIC CROWN, 1.25MM, 135CM SHAFT
10850026568087DIAMONDBACK CORONARY, CLASSIC CROWN, 1.25MM, 135CM SHAFT
10850026568698DIAMONDBACK CORONARY, CLASSIC CROWN, 1.25MM, 135CM SHAFT
10852528005442SALINE INFUSION PUMP (SIP)
10852528005800SALINE INFUSION PUMP (SIP)
10852528005787CORONARY ELECTRIC, CLASSIC CROWN, 1.25MM
10852528005336DIAMONDBACK 360® Coronary Orbital Atherectomy System, Micro Crown
30852528005187Guidewire, Viperwire Adavnce Coronary Floppy, .012: dia, .014" Spring Tip, 1 Pack 325 cm
10852528005176CORONARY ELECTRIC, CLASSIC CROWN, 1.50MM
10852528005169DIAMONDBACK CORONARY, CLASSIC CROWN, 1.25MM
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