Biotronik Passeo-35 HP 399097

GUDID 05391525781617

CREAGH MEDICAL LIMITED

Peripheral angioplasty balloon catheter, basic
Primary Device ID05391525781617
NIH Device Record Key70cf1710-1181-4099-8a9b-0bbdd8d40d16
Commercial Distribution StatusIn Commercial Distribution
Brand NameBiotronik Passeo-35 HP
Version Model Number12/40/75
Catalog Number399097
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
Length40 Millimeter
Outer Diameter12 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS105391525781617 [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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