| Primary Device ID | 00643169887435 |
| NIH Device Record Key | 0533f68e-c572-4716-b5d5-d0b78c7d611c |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | 3550-03 |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00643169887435 [Primary] |
| NHL | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS |
| 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 | 2017-10-08 |
| 00199150060467 - NA | 2025-11-28 CUSTOM PACK BB11Q49R14 EVL 3/8 EC |
| 00199150060627 - NA | 2025-11-28 CUSTOM PACK BB12M28R9 HLO QHLM-FROS |
| 00199150057177 - NA | 2025-11-24 CUSTOM PACK BB3Z71R34 HLO PRIMARY |
| 00199150058976 - NA | 2025-11-24 CUSTOM PACK PDBB12P71R2 HLO HEATT |
| 00199150060122 - NA | 2025-11-24 CUSTOM PACK BB12S52R1 EVL 3/8 PACK |
| 00763000849801 - Liberant™ | 2025-11-24 CONSOLE LMT-BCU LIBERANT |
| 00763000913069 - InterStim™ SureScan™ | 2025-11-24 LEAD 978A128 ISTM 2.16MM EUMDR EMAN LI08 |
| 00763000913083 - InterStim™ SureScan™ | 2025-11-24 LEAD 978A133 ISTM 2.16MM EMAN EUMDR LI08 |