Diamondback Coronary 7-10037-07

GUDID 10852528005800

SALINE INFUSION PUMP (SIP)

Cardiovascular Systems, Inc.

Atherectomy system saline/lubricant pump Atherectomy system saline/lubricant pump Atherectomy system saline/lubricant pump Atherectomy system saline/lubricant pump Atherectomy system saline/lubricant pump Atherectomy system saline/lubricant pump Atherectomy system saline/lubricant pump Atherectomy system saline/lubricant pump Atherectomy system saline/lubricant pump Atherectomy system saline/lubricant pump Atherectomy system saline/lubricant pump Atherectomy system saline/lubricant pump Atherectomy system saline/lubricant pump Atherectomy system saline/lubricant pump Atherectomy system saline/lubricant pump Atherectomy system saline/lubricant pump
Primary Device ID10852528005800
NIH Device Record Key05b62739-85ee-4774-bb13-3366ec1b94f6
Commercial Distribution StatusIn Commercial Distribution
Brand NameDiamondback Coronary
Version Model NumberSIP-3000
Catalog Number7-10037-07
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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone651-259-1600
Emailcustomerservice@csi360.com
Phone651-259-1600
Emailcustomerservice@csi360.com
Phone651-259-1600
Emailcustomerservice@csi360.com
Phone651-259-1600
Emailcustomerservice@csi360.com
Phone651-259-1600
Emailcustomerservice@csi360.com
Phone651-259-1600
Emailcustomerservice@csi360.com
Phone651-259-1600
Emailcustomerservice@csi360.com
Phone651-259-1600
Emailcustomerservice@csi360.com
Phone651-259-1600
Emailcustomerservice@csi360.com
Phone651-259-1600
Emailcustomerservice@csi360.com
Phone651-259-1600
Emailcustomerservice@csi360.com
Phone651-259-1600
Emailcustomerservice@csi360.com
Phone651-259-1600
Emailcustomerservice@csi360.com
Phone651-259-1600
Emailcustomerservice@csi360.com
Phone651-259-1600
Emailcustomerservice@csi360.com
Phone651-259-1600
Emailcustomerservice@csi360.com

Device Identifiers

Device Issuing AgencyDevice ID
GS110852528005800 [Primary]

FDA Product Code

MCXCatheter, Coronary, Atherectomy

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2023-12-18
Device Publish Date2018-07-20

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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