Diamondback Peripheral 7-10057-06

GUDID 10850000491226

Diamondback Peripheral, Solid Crown, 1.50MM, 200CM shaft

Cardiovascular Systems, Inc.

Mechanical atherectomy system catheter, peripheral
Primary Device ID10850000491226
NIH Device Record Key892e2e6a-ea95-41c7-8827-fff0b38159d7
Commercial Distribution StatusIn Commercial Distribution
Brand NameDiamondback Peripheral
Version Model NumberDBP-150SOLID200
Catalog Number7-10057-06
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

Device Dimensions

Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS110850000491226 [Primary]

FDA Product Code

MCWCatheter, Peripheral, Atherectomy

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[10850000491226]

Ethylene Oxide


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-11-21
Device Publish Date2019-11-13

On-Brand Devices [Diamondback Peripheral]

10850000491257DIAMONDBACK PERIPHERAL, CLASSIC CROWN, 2.00MM, 145CM SHAFT
10850000491240DIAMONDBACK PERIPHERAL, CLASSIC CROWN, 1.50MM, 145CM SHAFT
10850000491233Diamondback Peripheral, Solid Crown, 1.75MM, 180CM shaft
10850000491226Diamondback Peripheral, Solid Crown, 1.50MM, 200CM shaft
10850000491219Diamondback Peripheral, Solid Crown, 1.25MM, 200CM shaft
10850000491202DIAMONDBACK PERIPHERAL, SOLID CROWN, 2.00MM, 145CM SHAFT
10850000491196DIAMONDBACK PERIPHERAL, SOLID CROWN, 1.50MM, 145CM SHAFT
10850000491189DIAMONDBACK PERIPHERAL, SOLID CROWN, 1.25MM, 145CM SHAFT
10850000491172DIAMONDBACK PERIPHERAL, MICRO CROWN, 1.25MM, 145CM SHAFT

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