| Primary Device ID | 00763000004972 |
| NIH Device Record Key | 6cecc4e1-c23f-4dad-9dc0-da819d8507f1 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | 3550S-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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00763000004972 [Primary] |
| GXR | COVER, BURR HOLE |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-05-21 |
| Device Publish Date | 2019-05-13 |
| 00199150006045 - N/A | 2026-02-10 COMM HANDSET KIT TH90D01 DBS EMANUAL US |
| 00199150068302 - NA | 2026-02-10 CUSTOM PACK BB12M12R7 HLO CPB |
| 20199150068351 - NA | 2026-02-10 CUSTOM PACK 12C75R1 20PK ACC BIDMC-PCK |
| 20199150068382 - NA | 2026-02-10 CUSTOM PACK BB12C41R9 10PK ACC LNG PK |
| 00199150068869 - NA | 2026-02-10 CUSTOM PACK BB7V82R30 HLO L ADULT |
| 20199150068900 - NA | 2026-02-10 CUSTOM PACK BB12T59R 2PK ACC STOPCOCK P |
| 00199150068913 - NA | 2026-02-10 CUSTOM PACK BB11B96R6 HLO HEARTPACK |
| 00199150068968 - NA | 2026-02-10 CUSTOM PACK BB8R57R10 AVL AV1/2X |