| Primary Device ID | 20613994910770 |
| NIH Device Record Key | 882bde4c-d829-4850-8a63-891eb0c8a1a7 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | DSE0002 |
| 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 |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com |
| Length | 1.2 Meter |
| Length | 1.2 Meter |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00613994910776 [Primary] |
| GS1 | 20613994910770 [Package] Contains: 00613994910776 Package: PK [10 Units] In Commercial Distribution |
| GWJ | STIMULATOR, AUDITORY, 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 | 2016-04-30 |
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