| Primary Device ID | 00763000582470 |
| NIH Device Record Key | 9efb9fce-11e8-4a06-aab9-218be73b5262 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | TH90Q01 |
| 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 | true |
| Device Combination Product | false |
| Single Use | false |
| 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 | 00763000582470 [Primary] |
| EZW | Stimulator, electrical, implantable, for incontinence |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-03-14 |
| Device Publish Date | 2022-03-04 |
| 00199150027521 - Cardioblate™ | 2026-01-26 CLAMP 49321 CARDIOBLATE BP2 FT |
| 00199150027538 - Cardioblate™ | 2026-01-26 CLAMP 49341 CARDIOBLATE LP FT |
| 00199150027569 - Cardioblate™ | 2026-01-26 CARDIOBLATE 60831 BP2 DEVICE EN |
| 00199150027576 - Cardioblate® | 2026-01-26 CARDIOBLATE 60841 LP STANDALONE EN |
| 00763000999414 - SYNCHROMED™ III | 2026-01-23 PUMP 8667-20 SYNCHROMEDIII EMAN |
| 00763000999421 - SYNCHROMED™ III | 2026-01-23 PUMP 8667-40 SYNCHROMEDIII EMAN |
| 10681490185162 - NA | 2026-01-21 POUCH 8590-1 SYNCHROMED PUMP US |
| 00763000300623 - N/A | 2026-01-08 COMM HANDSET KIT TH90T01 TDD PROX MYPTM |