| Primary Device ID | 00613994499608 |
| NIH Device Record Key | a43e5d2f-dd46-45d3-950f-15bc3dc3635e |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | 8253085 |
| 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 | 00613994499608 [Primary] |
| GWF | STIMULATOR, ELECTRICAL, EVOKED RESPONSE |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-05-02 |
| 20763000281643 - Donldsn | 2024-04-30 VENT TUBE 1015101 5PK DONLDSN 1.14 FLPL |
| 20763000282992 - Shah | 2024-04-29 VENT TUBE 14311 5PK MINI SHAH .76MM FLPL |
| 00763000849573 - PTEYE Parathyroid Detection System | 2024-04-12 CONSOLE PTEYE |
| 00763000849580 - PTEYE Parathyroid Detection System | 2024-04-12 CONSOLE PTEYE-RF REFURBISHED |
| 00763000882389 - NIM | 2024-02-12 EMG TUBE 8229306 NIM STD 6MM ROHS |
| 00763000882396 - NIM | 2024-02-12 EMG TUBE 8229307 NIM STD 7MM ROHS |
| 00763000882402 - NIM | 2024-02-12 EMG TUBE 8229308 NIM STD 8MM ROHS |
| 00763000882419 - NIM | 2024-02-12 EMG TUBE 8229506 NIM CONT 6MM ROHS |