| Primary Device ID | 00850051682225 |
| NIH Device Record Key | 7eb31b7c-ea94-4955-8245-372c8e69bce3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Optional Forward Looking AR Headset |
| Version Model Number | 1 |
| Catalog Number | HC0210101 |
| Company DUNS | 080659059 |
| Company Name | OnPoint Surgical, Inc. |
| Device Count | 1 |
| DM Exempt | true |
| 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 | false |
| Serial Number | true |
| 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 | 888-241-2709 |
| support@onpointsurgical.com | |
| Phone | 888-241-2709 |
| support@onpointsurgical.com | |
| Phone | 888-241-2709 |
| support@onpointsurgical.com | |
| Phone | 888-241-2709 |
| support@onpointsurgical.com | |
| Phone | 888-241-2709 |
| support@onpointsurgical.com | |
| Phone | 888-241-2709 |
| support@onpointsurgical.com | |
| Phone | 888-241-2709 |
| support@onpointsurgical.com | |
| Phone | 888-241-2709 |
| support@onpointsurgical.com | |
| Phone | 888-241-2709 |
| support@onpointsurgical.com | |
| Phone | 888-241-2709 |
| support@onpointsurgical.com | |
| Phone | 888-241-2709 |
| support@onpointsurgical.com | |
| Phone | 888-241-2709 |
| support@onpointsurgical.com | |
| Phone | 888-241-2709 |
| support@onpointsurgical.com | |
| Phone | 888-241-2709 |
| support@onpointsurgical.com | |
| Phone | 888-241-2709 |
| support@onpointsurgical.com | |
| Phone | 888-241-2709 |
| support@onpointsurgical.com | |
| Phone | 888-241-2709 |
| support@onpointsurgical.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850051682225 [Primary] |
| SBF | Orthopedic Augmented Reality |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-10-14 |
| Device Publish Date | 2024-10-04 |
| 00850051682010 - OnPoint Surgical Cart | 2024-10-14 OnPoint Surgical Cart (with pre-installed software) - 1 headset |
| 00850051682027 - OnPoint Calibration Block | 2024-10-14 Calibration phantom |
| 00850051682034 - OnPoint Reusable Instrument Kit #1 | 2024-10-14 OnPoint Reusable Instrument Kit #1 with 1 Fixed Adapter, 3 Rotating Adapters, and 2 Power Adapters. |
| 00850051682041 - OnPoint Spine Clamp | 2024-10-14 OnPoint Spine Clamp |
| 00850051682058 - OnPoint Spinal Array | 2024-10-14 OnPoint Spinal Array |
| 00850051682065 - OnPoint Pelvic Pin | 2024-10-14 Pelvic Pin for MIS |
| 00850051682072 - OnPoint Pelvic Pin Adapter | 2024-10-14 Pelvic Pin Adapter for Spine Array |
| 00850051682089 - OnPoint Pelvic Pin Impactor Cap | 2024-10-14 Pelvic Pin Impactor Cap |