JETSTREAM SC 112260

GUDID 00616258005126

JETSTREAM SC 1.6MM, FG PKG

Bayer Healthcare LLC

Atherectomy/thrombectomy rotational catheter
Primary Device ID00616258005126
NIH Device Record Key431d8145-07c5-45af-a34c-37c97873db89
Commercial Distribution StatusIn Commercial Distribution
Brand NameJETSTREAM SC
Version Model Number112260-001
Catalog Number112260
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
GS100616258005126 [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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.