Rexall
DG OPP Contact Case 1CT
6manufacturers in China registered for this device type
1catalogue number
1510(k) clearance
Who Else Makes It
Concentrated in Shanghai (2), Guangdong (2), elsewhere (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shun SZE Industrial (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 22 |
| China (Shenyang) MED-Land IMP/EXP Corp., Ltd. | Shanghai | Shanghai | Exporter | 32 |
| Shanghai Care Us Medical Product Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 30 |
| Action Eyewear Corp. | Dong Guan | Guangdong | Contract manufacturer | 5 |
| Ningbo Kaida Rubber AND Plastic Technology Co., Ltd. | Yu Yao City, Zhejiang Province | Contract manufacturer | 2 | |
| Danyang Chanxin Glasses Cases Factory | Danyang | Jiangsu | Manufacturer | 1 |
Record
| Listed by | Apothecary Products, LLC., United States |
|---|---|
| FDA product code | LRX |
| Device type | Case, Contact Lens |
| Device class | Class 2 |
| Regulation | 21 CFR 886.5928 |
| Establishment | Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Record published | 2020-11-04 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Label carries | lot or batch number |
| Packaging | Inner of 6, case of 12 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 68090DG | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Optisource | Phoenix Medical Solutions | 18 |
| Bonasse | Bonasse Enterprises Co., Ltd. | 12 |
| Equate | Wal Mart Stores, Inc | 11 |
| Optego | Optego Vision USA, Inc. | 10 |
| UP & UP | Target Health, Inc. | 7 |
| Meijer | Meijer, Inc. | 6 |
| Flents | Apothecary Products, LLC. | 6 |
| Jingsheng | Ningbo Haishu Jingsheng Plastic Co., Ltd. | 4 |
| Bausch + Lomb | Bausch & Lomb Incorporated | 4 |
| Apex | Drive DeVilbiss Healthcare | 3 |
| Color Case | Watchdog Group, LC | 3 |
| Phoenix Healthcare Solutions LLC | Phoenix Medical Solutions | 3 |
Showing 12 of 52. All products under Case, Contact Lens
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K111856 | 2011-07-14 |
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.