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 |