| Primary Device ID | 03662663249041 |
| NIH Device Record Key | 97865983-91e3-4896-a806-6d16b549b9d5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Universal Navigation System |
| Version Model Number | 854M5040 |
| Catalog Number | 854M5040 |
| Company DUNS | 119260394 |
| Company Name | Highridge Medical, LLC |
| 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 | true |
| 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)447-3625 |
| usbrocustomerservice@highridgemedical.com | |
| Phone | +1(800)447-3625 |
| usbrocustomerservice@highridgemedical.com | |
| Phone | +1(800)447-3625 |
| usbrocustomerservice@highridgemedical.com | |
| Phone | +1(800)447-3625 |
| usbrocustomerservice@highridgemedical.com | |
| Phone | +1(800)447-3625 |
| usbrocustomerservice@highridgemedical.com | |
| Phone | +1(800)447-3625 |
| usbrocustomerservice@highridgemedical.com | |
| Phone | +1(800)447-3625 |
| usbrocustomerservice@highridgemedical.com | |
| Phone | +1(800)447-3625 |
| usbrocustomerservice@highridgemedical.com | |
| Phone | +1(800)447-3625 |
| usbrocustomerservice@highridgemedical.com | |
| Phone | +1(800)447-3625 |
| usbrocustomerservice@highridgemedical.com | |
| Phone | +1(800)447-3625 |
| usbrocustomerservice@highridgemedical.com | |
| Phone | +1(800)447-3625 |
| usbrocustomerservice@highridgemedical.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 03662663249041 [Primary] |
| OLO | Orthopedic stereotaxic instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[03662663249041]
Moist Heat or Steam Sterilization
[03662663249041]
Moist Heat or Steam Sterilization
[03662663249041]
Moist Heat or Steam Sterilization
[03662663249041]
Moist Heat or Steam Sterilization
[03662663249041]
Moist Heat or Steam Sterilization
[03662663249041]
Moist Heat or Steam Sterilization
[03662663249041]
Moist Heat or Steam Sterilization
[03662663249041]
Moist Heat or Steam Sterilization
[03662663249041]
Moist Heat or Steam Sterilization
[03662663249041]
Moist Heat or Steam Sterilization
[03662663249041]
Moist Heat or Steam Sterilization
[03662663249041]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-12-26 |
| Device Publish Date | 2025-12-18 |
| 03662663129428 | Standard AO Shaft |
| 03662663129411 | Large AO Shaft |
| 03662663129404 | 1/4 Square - Tri-Flat Shaft |
| 03662663129398 | 1/4" Square - 1/4" Square Shaft |
| 03662663218177 | PAT/PASIT STYLUS CASE |
| 03662663129466 | Array Support |
| 03662663129442 | Large & Standard AO Collet Nut |
| 03662663129435 | Square & Tri-Flat Collet Nut |
| 03662663249089 | PASIT STYLUS 60MM |
| 03662663249072 | PASIT STYLUS 55MM |
| 03662663249065 | PASIT STYLUS 50MM |
| 03662663249058 | PASIT STYLUS 45MM |
| 03662663249041 | PASIT STYLUS 40MM |
| 03662663249034 | PASIT STYLUS 35MM |
| 03662663249027 | PASIT STYLUS 30MM |
| 03662663249010 | PAT TAP STYLUS |