| Primary Device ID | 00763000299217 |
| NIH Device Record Key | 954170fa-fda0-4da6-91ec-0c296b73eae7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Indigo |
| Version Model Number | 1845040 |
| 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 | 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 | 00763000299217 [Primary] |
| HBE | DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-10-12 |
| Device Publish Date | 2020-10-03 |
| 00763000172893 | ATT 1845020-R INDIGO OTOL ANGLED REFURB |
| 00763000172886 | ATT 1845010-R INDIGO OTOL STRAIGHT RFURB |
| 00763000172879 | ATT 1845020 INDIGO OTOL ANGLED |
| 00763000172862 | ATT 1845010 INDIGO OTOL STRAIGHT |
| 00763000299217 | INSTRUMENT TRAY 1845040 INDIGO |