| Primary Device ID | 00643169887428 |
| NIH Device Record Key | 460f7330-6c9b-41d6-ab87-93986cee12e1 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | 3550-02 |
| 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 | 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 |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00643169887428 [Primary] |
| GZF | STIMULATOR, PERIPHERAL NERVE, IMPLANTED (PAIN RELIEF) |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2017-10-20 |
| 00763000893910 - SHERPA NX BALANCED™ | 2024-12-20 CATHETER SB6FL40SH SB 6F 100CM FL40 |
| 00763000893941 - SHERPA NX BALANCED™ | 2024-12-20 CATHETER SB6FR40SH SB 6F 100CM FR40 |
| 00763000988258 - NA | 2024-12-20 CUSTOM PACK BB10Q85R1 FILTER |
| 00763000988760 - NA | 2024-12-20 CUSTOM PACK BB1F66R26 CASPER |
| 00763000973391 - Sphere-9™ Catheter | 2024-12-16 CATHETER AFR-00001 SPHERE 9 Q-US AFR |
| 00763000986704 - NA | 2024-12-09 CUSTOM PACK BB7J97R20 1/4 PED CIRC |
| 00763000986773 - NA | 2024-12-09 CUSTOM PACK BB11N26R12 MASTER PACK |
| 20763000986814 - NA | 2024-12-09 CUSTOM PACK BB12G70R3 10PK SUPPLIES |