JETSTREAM XC 112266

GUDID 00616258005157

JETSTREAM XC 2.4MM, FG PKG

Bayer Healthcare LLC

Atherectomy/thrombectomy rotational catheter
Primary Device ID00616258005157
NIH Device Record Keyd6cee86b-4078-41ce-854b-35082b5bd276
Commercial Distribution StatusIn Commercial Distribution
Brand NameJETSTREAM XC
Version Model Number112266-001
Catalog Number112266
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
GS100616258005157 [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 XC]

00616258005157JETSTREAM XC 2.4MM, FG PKG
00616258005140JETSTREAM XC 2.1 MM, FG PKG

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