| Primary Device ID | 00192896075160 | 
| NIH Device Record Key | 43f65a1a-337b-4e3e-bbf9-ff7209588e8b | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | EYE SHIELD | 
| Version Model Number | 18-8020-SET | 
| Catalog Number | 18-8020-SET | 
| 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 Size Text, specify | 0 | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 00192896075160 [Primary] | 
| MDM | INSTRUMENT, MANUAL, SURGICAL, GENERAL USE | 
| MOE | Collagen Corneal Shield | 
| Steralize Prior To Use | true | 
| Device Is Sterile | false | 
[00192896075160]
Dry Heat Sterilization;Moist Heat or Steam Sterilization
| Public Version Status | Update | 
| Device Record Status | Published | 
| Public Version Number | 3 | 
| Public Version Date | 2019-11-08 | 
| Device Publish Date | 2018-10-04 | 
| 00192896075184 | EYE SHIELD SMOOTH SURFACE BLUE ELECTRO COATED | 
| 00192896075177 | EYE SHIELD PAIR SMOOTH SURFACE STAINLESS STEEL | 
| 00192896075160 | EYE SHIELD WITH HANDLE STAINLESS STEEL | 
| 00192896019614 | EYE SHIELD SMOOTH SURFACE STAINLESS STEEL | 
| 00192896019607 | EYE SHIELD WITH HANDLE BLUE ELECTRO COATED | 
| 00192896019591 | EYE SHIELD WITH HANDLE STAINLESS STEEL | 
| 00192896103399 | Cox II Eye Shield With Suction Cup Large Stainless Steel | 
| 00192896103382 | Cox II Eye Shield With Suction Cup Medium Stainless Steel | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  EYE SHIELD  87409970  not registered Dead/Abandoned | VITAMIN WORLD USA CORPORATION 2017-04-13 | 
|  EYE SHIELD  86551058  not registered Dead/Abandoned | Otis Products, Inc. 2015-03-03 | 
|  EYE SHIELD  76242635  not registered Dead/Abandoned | Cosmetic Dermatology, Inc. 2001-04-18 | 
|  EYE SHIELD  75561420  not registered Dead/Abandoned | Thibiant International, Inc. 1998-09-28 |