Annuloplasty Handle

GUDID 00763000612351

HANDLE 7615 ANNULOPLASTY 33L MDR

MEDTRONIC, INC.

Heart valve prosthesis sizer handle

• Primary Device ID: 00763000612351
• NIH Device Record Key: cba8a60f-d86a-4b56-a939-16e0784360c5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Annuloplasty Handle
• Version Model Number: 7615
• Company DUNS: 006261481
• Company Name: MEDTRONIC, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• 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: false
• 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
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com
• Phone: +1(800)633-8766
• Email: Corporate.UDI@medtronic.com

Device Dimensions

• Length: 216 Millimeter
• Length: 216 Millimeter
• Length: 216 Millimeter
• Length: 216 Millimeter
• Length: 216 Millimeter
• Length: 216 Millimeter
• Length: 216 Millimeter
• Length: 216 Millimeter
• Length: 216 Millimeter
• Length: 216 Millimeter
• Length: 216 Millimeter
• Length: 216 Millimeter
• Length: 216 Millimeter
• Length: 216 Millimeter
• Length: 216 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000612351 [Primary]

FDA Product Code

• DTJ: HOLDER, HEART-VALVE, PROSTHESIS

Sterilization

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

[00763000612351]

Moist Heat or Steam Sterilization

[00763000612351]

Moist Heat or Steam Sterilization

[00763000612351]

Moist Heat or Steam Sterilization

[00763000612351]

Moist Heat or Steam Sterilization

[00763000612351]

Moist Heat or Steam Sterilization

[00763000612351]

Moist Heat or Steam Sterilization

[00763000612351]

Moist Heat or Steam Sterilization

[00763000612351]

Moist Heat or Steam Sterilization

[00763000612351]

Moist Heat or Steam Sterilization

[00763000612351]

Moist Heat or Steam Sterilization

[00763000612351]

Moist Heat or Steam Sterilization

[00763000612351]

Moist Heat or Steam Sterilization

[00763000612351]

Moist Heat or Steam Sterilization

[00763000612351]

Moist Heat or Steam Sterilization

[00763000612351]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-03-28
• Device Publish Date: 2025-03-20

On-Brand Devices [Annuloplasty Handle]

• 00763000612368: HANDLE 7615XL ANNULOPLASTY 33L MDR
• 00763000612351: HANDLE 7615 ANNULOPLASTY 33L MDR
• 00643169707542: HANDLE 752 ANNULOPLASTY 254MM
• 00643169525627: HANDLE 7615XL ANNULOPLASTY 26L
• 00643169525641: HANDLE 7686XL ANNULOPLASTY 26L
• 00643169525634: HANDLE 7686 ANNULOPLASTY 26L
• 00643169525610: HANDLE 7615 ANNULOPLASTY 26L
• 00613994862488: TOOL 7686 ANNULOPLASTY HANDLE 216 MM 26L
• 00613994163516: TOOL 7615XL HANDLE ANLO 14L