| Primary Device ID | 00850029104018 |
| NIH Device Record Key | cc4b2230-9ee5-4096-96bc-c0e5deef63cc |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MYI OCCLUSION EYE PATCHES |
| Version Model Number | 007 |
| Company DUNS | 789337987 |
| Company Name | Fresnel Prism & Lens Company |
| Device Count | 17 |
| 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 | |
| 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 | 00850029104018 [Primary] |
| GS1 | 00850029104513 [Unit of Use] |
| GS1 | 00850029104551 [Package] Package: PACKETS of 17 [3 Units] In Commercial Distribution |
| GS1 | 10850029104558 [Package] Package: PACKETS of 17 [3 Units] In Commercial Distribution |
| HOY | Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2021-06-02 |
| Device Publish Date | 2021-03-29 |
| 08500291040041 | PACKET, JUNIOR, MYI EYE PATCH |
| 08500291040034 | PACKET, REGULAR, MYI EYE PATCH |
| 08500291040027 | PACKET, JUNIOR, MYI EYE PATCH |
| 08500291040010 | PACKET, REGULAR, MYI EYE PATCH |
| 00850029104575 | PACKET, JUNIOR, MYI EYE PATCH |
| 00850029104544 | PACKET, REGULAR, MYI EYE PATCH |
| 00850029104018 | PACKET, REGULAR, MYI EYE PATCH |
| 00850029104001 | PACKET, JUNIOR, MYI EYE PATCH |
| 10850029104572 | PACKET, JUNIOR, MYI EYE PATCH |
| 10850029104541 | PACKET, REGULAR, MYI EYE PATCH |