| Primary Device ID | 00811571030866 |
| NIH Device Record Key | 2424ba98-74d6-4311-9823-a67b9f010100 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Sharn Inc |
| Version Model Number | S2020 |
| Catalog Number | S2020 |
| Company DUNS | 115272845 |
| Company Name | CLEAR IMAGE DEVICES LLC |
| 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 | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Phone | 616-871-3247 |
| regulatoryaffairs@ascentbrandsinc.com | |
| Phone | 616-871-3247 |
| regulatoryaffairs@ascentbrandsinc.com | |
| Phone | 616-871-3247 |
| regulatoryaffairs@ascentbrandsinc.com | |
| Phone | 616-871-3247 |
| regulatoryaffairs@ascentbrandsinc.com | |
| Phone | 616-871-3247 |
| regulatoryaffairs@ascentbrandsinc.com | |
| Phone | 616-871-3247 |
| regulatoryaffairs@ascentbrandsinc.com | |
| Phone | 616-871-3247 |
| regulatoryaffairs@ascentbrandsinc.com | |
| Phone | 616-871-3247 |
| regulatoryaffairs@ascentbrandsinc.com | |
| Phone | 616-871-3247 |
| regulatoryaffairs@ascentbrandsinc.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00811571030866 [Primary] |
| GS1 | 00817518022109 [Previous] |
| 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 | 2021-08-30 |
| Device Publish Date | 2021-08-20 |
| 00811571030880 | EyeGard Pediatric |
| 00811571030873 | EyeGard Sensitive |
| 00811571030866 | EyeGard |
| 00811571030859 | EyeGuardian |
| 00811571030842 | EyeGuardian Sensitive |