| Primary Device ID | 08500291040195 |
| NIH Device Record Key | 643215ee-3300-4d82-801f-2a302f106279 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | VISION SCREENING PATCH |
| Version Model Number | IND5110B |
| Company DUNS | 789337987 |
| Company Name | Fresnel Prism & Lens Company |
| 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 | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
| Phone | 952-496-0432 |
| info@fresnelprism.com | |
| Phone | 952-496-0432 |
| info@fresnelprism.com | |
| Phone | 952-496-0432 |
| info@fresnelprism.com | |
| Phone | 952-496-0432 |
| info@fresnelprism.com | |
| Phone | 952-496-0432 |
| info@fresnelprism.com | |
| Phone | 952-496-0432 |
| info@fresnelprism.com | |
| Phone | 952-496-0432 |
| info@fresnelprism.com | |
| Phone | 952-496-0432 |
| info@fresnelprism.com | |
| Phone | 952-496-0432 |
| info@fresnelprism.com | |
| Phone | 952-496-0432 |
| info@fresnelprism.com | |
| Phone | 952-496-0432 |
| info@fresnelprism.com | |
| Phone | 952-496-0432 |
| info@fresnelprism.com | |
| Phone | 952-496-0432 |
| info@fresnelprism.com | |
| Phone | 952-496-0432 |
| info@fresnelprism.com | |
| Phone | 952-496-0432 |
| info@fresnelprism.com | |
| Phone | 952-496-0432 |
| info@fresnelprism.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08500291040195 [Primary] |
| HOY | Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-04-06 |
| Device Publish Date | 2021-03-29 |
| 08500291040195 | PATCH, VISION SCREENING, INDIVIDUAL |
| 08500291040201 | ROLL, PATCHES, VISION SCREENING |
| 00850029104124 | PATCH, VISION SCREENING, INDIVIDUAL |
| 00850029104452 | ROLL, PATCHES, VISION SCREENING |