Biotronik Passeo-35 HP 399082

GUDID 05391525781464

CREAGH MEDICAL LIMITED

Peripheral angioplasty balloon catheter, basic
Primary Device ID05391525781464
NIH Device Record Key6ed5fc60-d210-4767-b919-992e7099d1a1
Commercial Distribution StatusIn Commercial Distribution
Brand NameBiotronik Passeo-35 HP
Version Model Number5/60/75
Catalog Number399082
Company DUNS985021909
Company NameCREAGH MEDICAL LIMITED
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

Device Dimensions

Device Size Text, specify0
Length60 Millimeter
Outer Diameter5 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS105391525781464 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LITCatheter, Angioplasty, Peripheral, Transluminal

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-23

On-Brand Devices [Biotronik Passeo-35 HP]

0539152578161712/40/75
0539152578160010/40/75
053915257815949/40/75
053915257815878/80/75
053915257815708/60/75
053915257815638/40/75
053915257815568/20/75
053915257815497/100/75
053915257815327/60/75
053915257815257/40/75
053915257815187/20/75
053915257815016/100/75
053915257814956/60/75
053915257814886/40/75
053915257814716/20/75
053915257814645/60/75
053915257814575/40/75
053915257814405/20/75
053915257814334/40/75
053915257814264/20/75
053915257814193/40/75
053915257813588/40/40
053915257813107/40/40
053915257812736/40/40

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