| Primary Device ID | 20681490051174 |
| NIH Device Record Key | d3c74863-2a3b-4cf0-a9d7-61e272bd1537 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Hydroborated® |
| Version Model Number | 1922100 |
| Company DUNS | 835465063 |
| Company Name | MEDTRONIC XOMED, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | true |
| OTC Over-The-Counter | false |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com | |
| Phone | +1(800)633-8766 |
| Corporate.UDI@medtronic.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00681490051170 [Primary] |
| GS1 | 20681490051174 [Package] Contains: 00681490051170 Package: PK [3 Units] In Commercial Distribution |
| GFF | BUR, SURGICAL, GENERAL & PLASTIC SURGERY |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2017-09-09 |
| 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 |
| 20763000831480 - NIM™ | 2025-08-19 PROBE 8225490X 3PK INCREMENTING 1MM TIP |
| 20763000831497 - NIM™ | 2025-08-19 PROBE 8225825X 3PK INCREMT STD PRASS TIP |
| 00763000309480 - Causse/Polycel | 2025-07-01 PROSTHESIS 1156376 CAUSSE FLPL PARTIAL |
| 20763000870359 - Microgel | 2025-07-01 VENT TUBE 1082201 5PK PAPA TYPE 1.14 |
| 20763000870366 - Sheehy | 2025-07-01 VENT TUBE 1083301 5PK SHEEHY TYPE 1.27 |