| Primary Device ID | 00763000970079 |
| NIH Device Record Key | 6643aa5c-051d-48df-8e89-60cf1e8f4fb0 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | A52200 |
| 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 | 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 | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00763000970079 [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 | 2025-06-27 |
| Device Publish Date | 2025-06-19 |
| 10681490185162 - NA | 2026-01-21 POUCH 8590-1 SYNCHROMED PUMP US |
| 00763000300623 - N/A | 2026-01-08 COMM HANDSET KIT TH90T01 TDD PROX MYPTM |
| 00763000596958 - InterStim™ SureScan™ | 2026-01-08 LEAD 978B133 ISTM SSMRI 4.32MM EMAN GLBL |
| 00763000596996 - InterStim™ SureScan™ | 2026-01-08 LEAD 978B141 ISTM SSMRI 4.32MM EMAN GLBL |
| 00763000994198 - N/A | 2026-01-07 ACCY KIT 3550-68 TWIST LOCK SCRN CBL MDR |
| 00199150065684 - NA | 2026-01-06 CUSTOM PACK BB11W65R6 HLO SPECTRUM |
| 00199150065691 - NA | 2026-01-06 CUSTOM PACK BB6V93R18 EVL A 3/8 E |
| 00199150065745 - NA | 2026-01-06 CUSTOM PACK BB10V37R6 EVL 1/4 PED |