GUDID 00763000059446

ADHESIVE 080118 MEDICAL OUS US EIFU

MEDTRONIC, INC.

Medical device adhesive, sterile
Primary Device ID00763000059446
NIH Device Record Keyed6bfa0c-3bb4-4afd-9379-26d5e427eb1b
Commercial Distribution StatusIn Commercial Distribution
Version Model Number080118
Company DUNS006261481
Company NameMEDTRONIC, INC.
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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com
Phone+1(800)633-8766
EmailCorporate.UDI@medtronic.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 32 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 32 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100763000059446 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KFJMaterials, repair or replacement, pacemaker

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-01-22
Device Publish Date2018-12-22

Devices Manufactured by MEDTRONIC, INC.

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20763000770291 - TrailBlazer™2024-07-16 PS ASC-014-090 TRAILBLAZER ANGLED V04
20763000770307 - TrailBlazer™2024-07-16 PS ASC-014-135 TRAILBLAZER ANGLED V04
20763000770314 - TrailBlazer™2024-07-16 PS ASC-014-150 TRAILBLAZER ANGLED V04
20763000770321 - TrailBlazer™2024-07-16 PS ASC-018-090 TRAILBLAZER ANGLED V04
20763000770338 - TrailBlazer™2024-07-16 PS ASC-018-135 TRAILBLAZER ANGLED V04
20763000770345 - TrailBlazer™2024-07-16 PS ASC-018-150 TRAILBLAZER ANGLED V04
20763000770352 - TrailBlazer™2024-07-16 PS ASC-035-065 TRAILBLAZER ANGLED V04

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