| Primary Device ID | 09348227000122 |
| NIH Device Record Key | fadfcffc-00c1-4ca6-b7a9-a92d4f7aef6f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | VorOtek L Scope |
| Version Model Number | VSLS-2.5 L |
| Catalog Number | VSLS-2.5 L |
| Company DUNS | 744332997 |
| Company Name | VOROTEK PTY LTD |
| 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 | 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 09348227000122 [Primary] |
| HJH | Loupe, Binocular, Low Power |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-07-26 |
| Device Publish Date | 2023-07-18 |
| 09348227000122 | VorOtek L Scope - SpecFrame. 2.5X Magnification Loupes @ 47cm working distance with Fully Integr |
| 09348227000139 | VorOtek L Scope - SpecFrame. 2.5X Magnification Loupes @ 42cm working distance with Fully Integr |
| 09348227000108 | VorOtek L Scope - HeadBand 2.5X Magnification Loupes @ 42cm working distance with Fully Integrat |
| 09348227000092 | VorOtek L Scope - HeadBand. 2.5X Magnification Loupes @ 47cm working distance with Fully Integra |