JETSTREAM SC 112262

GUDID 00616258005133

JETSTREAM SC 1.85MM, FG PKG

Bayer Healthcare LLC

Atherectomy/thrombectomy rotational catheter
Primary Device ID00616258005133
NIH Device Record Keyae3fa261-4d7e-4f9d-a44e-02e7eb97d34e
Commercial Distribution StatusIn Commercial Distribution
Brand NameJETSTREAM SC
Version Model Number112262-001
Catalog Number112262
Company DUNS079415061
Company NameBayer Healthcare LLC
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone763-780-4555
Emailmichael.burnside@bayer.com
Phone763-780-4555
Emailmichael.burnside@bayer.com

Device Dimensions

Catheter Gauge7 French
Catheter Gauge7 French

Device Identifiers

Device Issuing AgencyDevice ID
GS100616258005133 [Primary]

FDA Product Code

MCWCatheter, Peripheral, Atherectomy

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2014-10-09

On-Brand Devices [JETSTREAM SC]

00616258005133JETSTREAM SC 1.85MM, FG PKG
00616258005126JETSTREAM SC 1.6MM, FG PKG

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