| Primary Device ID | 00850007069391 |
| NIH Device Record Key | 04f843bb-f1f6-486e-aceb-313db846d716 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Imager Adaptor for Alphatec PTP™ Retractor |
| Version Model Number | ATC-S |
| Company DUNS | 096680671 |
| Company Name | VISEON, INC. |
| Device Count | 5 |
| 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 | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850007069391 [Unit of Use] |
| GS1 | 00850007069421 [Primary] |
| FSO | Microscope, Surgical, General & Plastic Surgery |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-02-13 |
| Device Publish Date | 2024-02-05 |
| 00850007069650 - MISScope 4K | 2024-02-14 MISScope 4K, 18 Dia, 50L |
| 00850007069346 - MaxView System - Lateral Set | 2024-02-13 MaxView System - Lateral Set Gen 2, Short |
| 00850007069353 - MaxView System - Lateral Set | 2024-02-13 MaxView System - Lateral Set Gen 2, Long |
| 00850007069360 - Imager Adaptor for NuVasive® MaXcess® 4 Retractor | 2024-02-13 Imager Adaptor for NuVasive® MaXcess® 4 Retractor, 5 -pk Carton |
| 00850007069377 - Imager Adaptor for Globus Mars™3VL Retractor | 2024-02-13 Imager Adaptor for Globus Mars™3VL Retractor, 5-pk Carton |
| 00850007069391 - Imager Adaptor for Alphatec PTP™ Retractor | 2024-02-13Imager Adaptor for Alphatec PTP™ Retractor, 5-pk Carton |
| 00850007069391 - Imager Adaptor for Alphatec PTP™ Retractor | 2024-02-13 Imager Adaptor for Alphatec PTP™ Retractor, 5-pk Carton |
| 00850007069445 - Image Control Box | 2024-02-13 Image Control Box (ICB-4K) |
| 00850007069438 - Imager Adaptor for Stryker Niagra® Retractor | 2024-02-13 Imager Adaptor for Stryker Niagra® Retractor, 5-pk Carton |