| Primary Device ID | 00850029104414 |
| NIH Device Record Key | 6c697cf9-5bc8-4e42-ad6b-27a932e8d635 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | FRESNEL PRISM AND LENS |
| Version Model Number | 6300-1 |
| Catalog Number | 6300-1 |
| 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 | false |
| Lot Batch | false |
| Serial Number | false |
| 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 | 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 | |
| Phone | 952-496-0432 |
| info@fresnelprism.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850029104414 [Primary] |
| NXR | Fixation, Vision Training, Binocular |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2021-05-27 |
| Device Publish Date | 2021-03-29 |
| 08500291040492 | FOIL BAR |
| 08500291040485 | TRIAL RING - 40 DIOPTER NO HANDLE |
| 08500291040478 | TRIAL RING - 35 DIOPTER NO HANDLE |
| 08500291040461 | TRIAL RING - 30 DIOPTER NO HANDLE |
| 08500291040454 | TRIAL RING - 25 DIOPTER NO HANDLE |
| 08500291040447 | TRIAL RING - 20 DIOPTER NO HANDLE |
| 08500291040430 | TRIAL RING - 15 DIOPTER NO HANDLE |
| 08500291040423 | TRIAL RING - 12 DIOPTER NO HANDLE |
| 08500291040416 | TRIAL RING - 10 DIOPTER NO HANDLE |
| 08500291040409 | TRIAL RING - 8 DIOPTER NO HANDLE |
| 08500291040393 | TRIAL RING - 6 DIOPTER NO HANDLE |
| 08500291040386 | TRIAL RING - 5 DIOPTER NO HANDLE |
| 08500291040379 | TRIAL RING - 4 DIOPTER NO HANDLE |
| 08500291040362 | TRIAL RING - 3 DIOPTER NO HANDLE |
| 08500291040355 | TRIAL RING - 2 DIOPTER NO HANDLE |
| 08500291040348 | TRIAL RING - 40 DIOPTER |
| 08500291040331 | TRIAL RING - 35 DIOPTER |
| 08500291040324 | TRIAL RING - 30 DIOPTER |
| 08500291040317 | TRIAL RING - 25 DIOPTER |
| 08500291040300 | TRIAL RING - 20 DIOPTER |
| 08500291040294 | TRIAL RING - 15 DIOPTER |
| 08500291040287 | TRIAL RING - 12 DIOPTER |
| 08500291040270 | TRIAL RING - 10 DIOPTER |
| 08500291040263 | TRIAL RING - 8 DIOPTER |
| 08500291040256 | TRIAL RING - 6 DIOPTER |
| 08500291040249 | TRIAL RING - 5 DIOPTER |
| 08500291040232 | TRIAL RING - 4 DIOPTER |
| 08500291040225 | TRIAL RING - 3 DIOPTER |
| 08500291040218 | TRIAL RING - 2 DIOPTER |
| 08500291040171 | LENS, OCCLUSION, MIN, CR-39 |
| 08500291040614 | SET, LENS, TRIAL, FRESNEL PRISM, NO HANDLES, 12 - 40 DIOPTER |
| 08500291040607 | SET, LENS, TRIAL, FRESNEL PRISM, NO HANDLES, 2 - 10 DIOPTER |
| 08500291040591 | SET, LENS, TRIAL, FRESNEL PRISM, 12 - 40 DIOPTER |
| 08500291040584 | SET, LENS, TRIAL, FRESNEL PRISM, 2 - 10 DIOPTER |
| 00850029104414 | FOIL BAR |
| 00850029104407 | TRIAL RING - 40 DIOPTER NO HANDLE |
| 00850029104391 | TRIAL RING - 35 DIOPTER NO HANDLE |
| 00850029104384 | TRIAL RING - 30 DIOPTER NO HANDLE |
| 00850029104377 | TRIAL RING - 25 DIOPTER NO HANDLE |
| 00850029104360 | TRIAL RING - 20 DIOPTER NO HANDLE |
| 00850029104353 | TRIAL RING - 15 DIOPTER NO HANDLE |
| 00850029104346 | TRIAL RING - 12 DIOPTER NO HANDLE |
| 00850029104339 | TRIAL RING - 10 DIOPTER NO HANDLE |
| 00850029104322 | TRIAL RING - 8 DIOPTER NO HANDLE |
| 00850029104315 | TRIAL RING - 6 DIOPTER NO HANDLE |
| 00850029104308 | TRIAL RING - 5 DIOPTER NO HANDLE |
| 00850029104292 | TRIAL RING - 4 DIOPTER NO HANDLE |
| 00850029104285 | TRIAL RING - 3 DIOPTER NO HANDLE |
| 00850029104278 | TRIAL RING - 2 DIOPTER NO HANDLE |
| 00850029104261 | TRIAL RING - 40 DIOPTER |