GUDID 00763000059446

ADHESIVE 080118 MEDICAL OUS US EIFU

MEDTRONIC, INC.

Medical device adhesive, sterile

• Primary Device ID: 00763000059446
• NIH Device Record Key: ed6bfa0c-3bb4-4afd-9379-26d5e427eb1b
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 080118
• Company DUNS: 006261481
• Company Name: MEDTRONIC, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 32 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 32 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000059446 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P830061

FDA Product Code

• KFJ: Materials, repair or replacement, pacemaker

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-01-22
• Device Publish Date: 2018-12-22

Devices Manufactured by MEDTRONIC, INC.

• 00613994163516 - Annuloplasty Handle: 2025-12-30 TOOL 7615XL HANDLE ANLO 14L
• 00613994838087 - Contour 3D™: 2025-12-30 TOOL 7690S CNTOUR 3D SZRSET REUSABLE 26L
• 00613994862488 - Annuloplasty Handle: 2025-12-30 TOOL 7686 ANNULOPLASTY HANDLE 216 MM 26L
• 00613994867988 - Medtronic Open Pivot™: 2025-12-30 ACCY 576 MHV SIZER SET
• 00643169525603 - Duran AnCore™: 2025-12-30 SIZER SET 7620S DURAN ANCORE 26L
• 00643169525610 - Annuloplasty Handle: 2025-12-30 HANDLE 7615 ANNULOPLASTY 26L
• 00643169525634 - Annuloplasty Handle: 2025-12-30 HANDLE 7686 ANNULOPLASTY 26L
• 00643169525641 - Annuloplasty Handle: 2025-12-30 HANDLE 7686XL ANNULOPLASTY 26L