| Primary Device ID | 00192896047501 |
| NIH Device Record Key | 3f8754be-3993-4e3b-bb46-4e2d178bb874 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CORNEAL EYE SHIELD |
| Version Model Number | 1100-409SC |
| Catalog Number | 1100-409SC |
| 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1(800) 821-7496 |
| info@sontecinstruments.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00192896047501 [Primary] |
| MDM | INSTRUMENT, MANUAL, SURGICAL, GENERAL USE |
| MOE | Collagen Corneal Shield |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00192896047501]
Moist Heat or Steam Sterilization;Dry Heat Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2019-08-26 |
| Device Publish Date | 2018-09-17 |
| 00192896047525 | CORNEAL EYE SHIELD SMALL SIZE WHITE PLASTIC |
| 00192896047518 | CORNEAL EYE SHIELD SMALL SIZE GREEN PLASTIC |
| 00192896047501 | CORNEAL EYE SHIELD SMALL SIZE CLEAR PLASTIC |
| 00192896047488 | CORNEAL EYE SHIELD PEDIATRIC SIZE GREEN PLASTIC |
| 00192896047464 | CORNEAL EYE SHIELD MEDIUM SIZE GREEN PLASTIC |
| 00192896047457 | CORNEAL EYE SHIELD MEDIUM SIZE CLEAR PLASTIC |
| 00192896047433 | CORNEAL EYE SHIELD LARGE SIZE GREEN PLASTIC |
| 00192896047426 | CORNEAL EYE SHIELD LARGE SIZE CLEAR PLASTIC |