| Primary Device ID | 00643169719828 |
| NIH Device Record Key | 3a9eece7-c11d-4047-a1f5-a88b5805d6ab |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | S0264-31 |
| Company DUNS | 835465063 |
| Company Name | MEDTRONIC XOMED, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00643169719828 [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 | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2017-10-02 |
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| 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 |
| 00763000956028 - Tubing Set | 2026-02-23 IRRIG SET 3318604E IPC SUCTION W/RC |
| 00643169547087 - NIM® | 2025-09-22 MAINFRAME 8253402 NEURO 3.0 INTL EL ROHS |
| 00763000745080 - NuVent™ | 2025-08-25 INFLATOR KIT 18INFKIT BALLOON |
| 00763000831479 - NIM™ | 2025-08-19 PROBE NIMDTP35 ENDO 35CM 1MM BALL TIP |