| Primary Device ID | 00613994870919 |
| NIH Device Record Key | 376d208f-dd05-4851-81e4-efec1af49724 |
| Commercial Distribution Status | In Commercial Distribution |
| Version Model Number | RSE1000 |
| 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 | 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 | false |
| OTC Over-The-Counter | false |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00613994870919 [Primary] |
| GXY | ELECTRODE, CUTANEOUS |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00613994870919]
Moist Heat or Steam Sterilization
[00613994870919]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-05-05 |
| 00763000033385 - HA/C Polycel® Brackmann Total | 2024-05-20 PROSTHESIS 1112303 BRACKMANN H/AC TOTAL |
| 00763000034832 - Sheehy HA/C Polycel® P.O.P. | 2024-05-20 PROSTHESIS 1112362 SHEEHY POP H/A POLYCL |
| 00763000034849 - Sheehy HA/C Polycel® T.O.P. | 2024-05-20 PROSTHESIS 1112363 SHEEHY TOP H/A POLYCL |
| 00763000036591 - Big Easy® Piston | 2024-05-20 PROSTHESIS 1156611 PLAT/TI .5X4.5MM LFT |
| 00763000036607 - Big Easy® Piston | 2024-05-20 PROSTHESIS 1156612 PLAT/TI .5X4.75MM LFT |
| 00763000036614 - Big Easy® Piston | 2024-05-20 PROSTHESIS 1156613 PLAT/TI .5X5MM LEFT |
| 00763000036621 - Big Easy® Piston | 2024-05-20 PROSTHESIS 1156621 PLAT/TI .5X4.5MM RT |
| 00763000036638 - Big Easy® Piston | 2024-05-20 PROSTHESIS 1156622 PLAT/TI .5X4.75M RT |