Eye Shield
Cox II Eye Shield With Suction Cup Medium Stainless Steel
1manufacturer
2catalogue numbers in this listing
Who Else Makes It
Registered in Fujian.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Cheng YI Optical (Xiamen) Co., Ltd. | Xiamen | Fujian | Manufacturer | 8 |
Record
| Listed by | Sontec Instruments, Inc., United States |
|---|---|
| FDA product code | MOE |
| Device type | Collagen Corneal Shield |
| Device class | Class 1 |
| Regulation | 21 CFR 886.4750 |
| Establishment | Repacker / relabeller |
| Premarket notification | Exempt |
| Record published | 2020-07-13 |
| Record revised | 2025-10-29 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization, Dry Heat Sterilization |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number |
| Distribution end date | 2023-08-11 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 18-8038 | Sphere 25.5 x 23 Millimeter | Withdrawn |
| 18-8039 | Sphere 27 x 24 Millimeter | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Ocular Shield | Sontec Instruments, Inc. | 10 |
| Corneal EYE Shield | Sontec Instruments, Inc. | 8 |
| Soft Shield® Collagen Shields | Oasis Medical, Inc. | 5 |
| COX II H EYE Shield | Sontec Instruments, Inc. | 4 |
| COX II EYE Shield | Sontec Instruments, Inc. | 2 |
| Suction CUP Handle | Sontec Instruments, Inc. | 1 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.