| Primary Device ID | 00613994644992 |
| NIH Device Record Key | bbb632da-d109-4ed7-9199-b0223c7a2ae7 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | 40R2000 |
| Company DUNS | 835465063 |
| Company Name | MEDTRONIC XOMED, 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 |
| Length | 4 Millimeter |
| Length | 4 Millimeter |
| Length | 4 Millimeter |
| Length | 4 Millimeter |
| Length | 4 Millimeter |
| Length | 4 Millimeter |
| Length | 4 Millimeter |
| Length | 4 Millimeter |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00613994644992 [Primary] |
| HBE | DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) |
| 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 | 2016-07-30 |
| 00199150023851 - N/A | 2026-02-24 PROBE 8225101E PRASS STD PROT HANDLE |
| 00199150023868 - N/A | 2026-02-24 PROBE 8225101 5PK PRASS STD PROT HANDLE |
| 00199150023875 - N/A | 2026-02-24 PROBE 8225110 10PK PRASS STD |
| 00199150023882 - N/A | 2026-02-24 PROBE 8225103 5PK PRASS SLIM PROT HANDLE |
| 00763000548797 - Hydrodebrider | 2026-02-23 HYDRODEBRIDER 1914001 STD HANDPIECE ROHS |
| 00763000548803 - Hydrodebrider | 2026-02-23 HANDPIECE 1921002 HYDRODEBRID FRNTL ROHS |
| 20763000888910 - Merocel | 2026-02-23 PACKING 400151 100PK MICRO SPHERES 4MM |
| 20763000888927 - Merocel | 2026-02-23 PACKING 400152 100PK MICRO SPHERES 5MM |