| Primary Device ID | 00643169841796 |
| NIH Device Record Key | 7adbf346-3818-494a-9a66-c2486d901788 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | S0278-00 |
| 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 | 00643169841796 [Primary] |
| LXB | Hearing aid, bone conduction |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2018-10-22 |
| Device Publish Date | 2016-09-29 |
| 00763000891862 - ENT NIM Electrode | 2024-10-01 PROBE 8225275 BALL TIP 1MM ROHS |
| 00763000891879 - ENT NIM Electrode | 2024-10-01 PROBE 8225276 BALL TIP 2.3MM ROHS |
| 00763000580483 - ENT NIM Vital | 2024-09-27 CABLE 1352415 STIM DISSECTION 3M ROHS |
| 00763000578022 - N/A | 2024-09-24 SPLINT 1528110 25PK EXTERNAL NASAL SMALL |
| 00763000578039 - N/A | 2024-09-24 SPLINT 1528111 5PK EXTERNAL NASAL SMALL |
| 00763000578046 - N/A | 2024-09-24 SPLINT 1528120 25PK EXTERNAL NASAL MED |
| 00763000578053 - N/A | 2024-09-24 SPLINT 1528121 5PK EXTERNAL NASAL MEDIUM |
| 00763000578060 - N/A | 2024-09-24 SPLINT 1528137 25PK EXTERNAL NASAL LARGE |