Diamondback Coroanry 70058-12

GUDID 10852528005428

CORONARY ELECTRIC, CLASSIC CROWN, 1.25MM

Cardiovascular Systems, Inc.

Mechanical atherectomy system, coronary, line-powered
Primary Device ID10852528005428
NIH Device Record Key1767bc5f-d535-49d2-a583-473bca723fee
Commercial Distribution StatusIn Commercial Distribution
Brand NameDiamondback Coroanry
Version Model NumberDBEC-125
Catalog Number70058-12
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

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Device Identifiers

Device Issuing AgencyDevice ID
GS110852528005428 [Primary]

FDA Product Code

MCXCatheter, Coronary, Atherectomy

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[10852528005428]

Ethylene Oxide


[10852528005428]

Ethylene Oxide


[10852528005428]

Ethylene Oxide


[10852528005428]

Ethylene Oxide


[10852528005428]

Ethylene Oxide


[10852528005428]

Ethylene Oxide


[10852528005428]

Ethylene Oxide


[10852528005428]

Ethylene Oxide


[10852528005428]

Ethylene Oxide


[10852528005428]

Ethylene Oxide


[10852528005428]

Ethylene Oxide


[10852528005428]

Ethylene Oxide


[10852528005428]

Ethylene Oxide


[10852528005428]

Ethylene Oxide


[10852528005428]

Ethylene Oxide


[10852528005428]

Ethylene Oxide


[10852528005428]

Ethylene Oxide


[10852528005428]

Ethylene Oxide


[10852528005428]

Ethylene Oxide


[10852528005428]

Ethylene Oxide


[10852528005428]

Ethylene Oxide


[10852528005428]

Ethylene Oxide


[10852528005428]

Ethylene Oxide


[10852528005428]

Ethylene Oxide


[10852528005428]

Ethylene Oxide


[10852528005428]

Ethylene Oxide


[10852528005428]

Ethylene Oxide


[10852528005428]

Ethylene Oxide


[10852528005428]

Ethylene Oxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2023-12-18
Device Publish Date2017-11-02

Devices Manufactured by Cardiovascular Systems, Inc.

10852528005114 - ViperTrack2026-01-13 VIPERTRACK, 20 PACK
10852528005077 - ViperWire, Advance2025-12-25 VIPERWIRE, ADVANCE PERIPHERAL, .014" DIA SPRING TIP, 335CM, 5 PACK
10852528005084 - ViperWire, Advance2025-12-25 VIPERWIRE, ADVANCE PERIPHERAL, .017" DIA SPRING TIP, 335CM, 5 PACK
10852528005107 - ViperTrack2025-12-25 VIPERTRACK, 50 PACK
10852528005121 - Viperslide2025-12-25 VIPERSLIDE, 100ML BAG, 10 PK
10852528005183 - ViperWire2025-12-25 Guidewire, Viperwire Adavnce Coronary Floppy, .012: dia, .014" Spring Tip, 1 Pack 325 cm
10852528005459 - Extended Length ViperWire Advance 2025-12-25 ViperWire, Advance, Extended Length, Peripheral, 0.014" Dia spring tip, 475cm, 5 Pack
10852528005701 - ViperWire2025-12-25 Guidewire, Viperwire Advance Coronary Flex Tip .014: dia, .012" 1 Pack 325 cm

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