Soft Shield® Collagen Shields
SOFT SHIELD® Collagen Shield, 12 Hours (CE)
1manufacturer
5catalogue numbers in this listing
1510(k) clearance
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 | Oasis Medical, Inc., United States |
|---|---|
| FDA product code | MOE |
| Device type | Collagen Corneal Shield |
| Device class | Class 1 |
| Regulation | 21 CFR 886.4750 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2023-06-30 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Radiation Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Packaging | Carton of 10, carton of 6 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 7012 | In distribution | |
| 7072 | In distribution | |
| 7172 | In distribution | |
| 7024 | In distribution | |
| 7002 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Ocular Shield | Sontec Instruments, Inc. | 10 |
| Corneal EYE Shield | Sontec Instruments, Inc. | 8 |
| COX II H EYE Shield | Sontec Instruments, Inc. | 4 |
| COX II EYE Shield | Sontec Instruments, Inc. | 2 |
| Eye Shield | Sontec Instruments, Inc. | 2 |
| Suction CUP Handle | Sontec Instruments, Inc. | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K914529 | 1991-11-13 |
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.