| Primary Device ID | 00192896095373 | 
| NIH Device Record Key | 203c7ad8-1e10-49cb-9a63-26b09a513ca5 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | COX II H EYE SHIELD | 
| Version Model Number | 18-8032R | 
| Catalog Number | 18-8032R | 
| Company DUNS | 040729840 | 
| Company Name | SONTEC INSTRUMENTS, INC. | 
| 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 | true | 
| Serial Number | false | 
| Manufacturing Date | false | 
| Expiration Date | false | 
| Donation Id Number | false | 
| Contains Natural Rubber Latex | false | 
| Labeled No Natural Rubber Latex | true | 
| RX Perscription | true | 
| OTC Over-The-Counter | false | 
| Phone | +1(800) 821-7496 | 
| info@sontecinstruments.com | |
| Phone | +1(800) 821-7496 | 
| info@sontecinstruments.com | |
| Phone | +1(800) 821-7496 | 
| info@sontecinstruments.com | |
| Phone | +1(800) 821-7496 | 
| info@sontecinstruments.com | |
| Phone | +1(800) 821-7496 | 
| info@sontecinstruments.com | |
| Phone | +1(800) 821-7496 | 
| info@sontecinstruments.com | |
| Phone | +1(800) 821-7496 | 
| info@sontecinstruments.com | |
| Phone | +1(800) 821-7496 | 
| info@sontecinstruments.com | |
| Phone | +1(800) 821-7496 | 
| info@sontecinstruments.com | |
| Phone | +1(800) 821-7496 | 
| info@sontecinstruments.com | |
| Phone | +1(800) 821-7496 | 
| info@sontecinstruments.com | |
| Phone | +1(800) 821-7496 | 
| info@sontecinstruments.com | |
| Phone | +1(800) 821-7496 | 
| info@sontecinstruments.com | |
| Phone | +1(800) 821-7496 | 
| info@sontecinstruments.com | |
| Phone | +1(800) 821-7496 | 
| info@sontecinstruments.com | |
| Phone | +1(800) 821-7496 | 
| info@sontecinstruments.com | |
| Phone | +1(800) 821-7496 | 
| info@sontecinstruments.com | |
| Phone | +1(800) 821-7496 | 
| info@sontecinstruments.com | 
| Device Size Text, specify | 0 | 
| Device Size Text, specify | 0 | 
| Device Size Text, specify | 0 | 
| Device Size Text, specify | 0 | 
| Device Size Text, specify | 0 | 
| Device Size Text, specify | 0 | 
| Device Size Text, specify | 0 | 
| Device Size Text, specify | 0 | 
| Device Size Text, specify | 0 | 
| Device Size Text, specify | 0 | 
| Device Size Text, specify | 0 | 
| Device Size Text, specify | 0 | 
| Device Size Text, specify | 0 | 
| Device Size Text, specify | 0 | 
| Device Size Text, specify | 0 | 
| Device Size Text, specify | 0 | 
| Device Size Text, specify | 0 | 
| Device Size Text, specify | 0 | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 00192896095373 [Primary] | 
| MOE | Collagen Corneal Shield | 
| Steralize Prior To Use | true | 
| Device Is Sterile | false | 
[00192896095373]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
[00192896095373]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
[00192896095373]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
[00192896095373]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
[00192896095373]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
[00192896095373]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
[00192896095373]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
[00192896095373]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
[00192896095373]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
[00192896095373]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
[00192896095373]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
[00192896095373]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
[00192896095373]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
[00192896095373]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
[00192896095373]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
[00192896095373]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
[00192896095373]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
[00192896095373]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
| Public Version Status | Update | 
| Device Record Status | Published | 
| Public Version Number | 3 | 
| Public Version Date | 2019-11-11 | 
| Device Publish Date | 2019-03-07 | 
| 00192896095373 | COX II H EYE SHIELD MEDIUM SIZE OFFSET RIGHT SIDE STAINLESS STEEL | 
| 00192896095366 | COX II H EYE SHIELD MEDIUM SIZE OFFSET LEFT SIDE STAINLESS STEEL | 
| 00192896109780 | Cox II H Eye Shield Offset Handle Small Right Side Stainless Steel 24 X 21 Millimeter | 
| 00192896109773 | Cox II H Eye Shield Offset Handle Small Left Side Stainless Steel 24 X 21 Millimeter |