| Primary Device ID | 00763000825515 |
| NIH Device Record Key | bc2b1fb3-4834-45b4-80b2-7db29227c670 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | 8596SC |
| Company DUNS | 796986144 |
| 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 | true |
| Single Use | true |
| Lot Batch | false |
| Serial Number | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00763000825515 [Primary] |
| LKK | Pump, infusion, implanted, programmable |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-12-18 |
| Device Publish Date | 2023-12-09 |
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| 00643169525603 - Duran AnCore™ | 2025-12-30 SIZER SET 7620S DURAN ANCORE 26L |
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| 00643169525634 - Annuloplasty Handle | 2025-12-30 HANDLE 7686 ANNULOPLASTY 26L |
| 00643169525641 - Annuloplasty Handle | 2025-12-30 HANDLE 7686XL ANNULOPLASTY 26L |