GUDID 00802526489280

Medical Adhesive

BOSTON SCIENTIFIC CORPORATION

Medical device adhesive, sterile
Primary Device ID00802526489280
NIH Device Record Key0c38861a-f1d5-4e73-acfa-d807a411a95a
Commercial Distribution StatusIn Commercial Distribution
Version Model Number6517
Company DUNS106295384
Company NameBOSTON SCIENTIFIC CORPORATION
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 Usefalse
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 Identifiers

Device Issuing AgencyDevice ID
GS100802526489280 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LWPImplantable pulse generator, pacemaker (non-CRT)

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 Date2014-09-24

Devices Manufactured by BOSTON SCIENTIFIC CORPORATION

08714729839538 - Direxion™ HI-FLO™2024-09-25 Torqueable Microcatheter
08714729839569 - Direxion™ HI-FLO™2024-09-25 Torqueable Microcatheter
08714729991069 - Direxion™ HI-FLO™ Fathom™-16 System2024-09-25 Pre-Loaded Torqueable Microcatheter
08714729991076 - Direxion™ HI-FLO™ Fathom™-16 System2024-09-25 Pre-Loaded Torqueable Microcatheter
08714729991083 - Direxion™ Fathom™-16 System2024-09-25 Pre-Loaded Torqueable Microcatheter
08714729991090 - Direxion™ Fathom™-16 System2024-09-25 Pre-Loaded Torqueable Microcatheter
08714729845331 - Gateway Advantage2024-09-23 Y-Adapter
08714729880912 - LithoVue2024-09-23 System Workstation

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