| Primary Device ID | 00763000185121 |
| NIH Device Record Key | 5f935bbc-cf28-4d6b-87da-34751e500ff6 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | FP6000S |
| Company DUNS | 006261481 |
| 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 | 00763000185121 [Primary] |
| MHY | Stimulator, electrical, implanted, for parkinsonian tremor |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-07-20 |
| Device Publish Date | 2020-07-12 |
| 20199150041118 - NA | 2025-08-18 CUSTOM PACK BB12E30R1 10PK ACC BRIDGE |
| 20199150041132 - NA | 2025-08-18 CUSTOM PACK BB5G89R2 2PK T SPRT |
| 00763000876982 - SPRINTER® LEGEND | 2025-08-18 BALLOON SPL12506X SPR LEG RX US M |
| 00763000876999 - SPRINTER® LEGEND | 2025-08-18 BALLOON SPL12510X SPR LEG RX US M |
| 00763000877002 - SPRINTER® LEGEND | 2025-08-18 BALLOON SPL12512X SPR LEG RX US M |
| 00763000877019 - SPRINTER® LEGEND | 2025-08-18 BALLOON SPL12515X SPR LEG RX US M |
| 00763000877026 - SPRINTER® LEGEND | 2025-08-18 BALLOON SPL12520X SPR LEG RX US M |
| 00763000925079 - FlexCath Cross™ Transseptal Solution | 2025-08-18 NDL 900300 FLEXCATH CROSS AG 61CM EIFU |