Regard™
Drape Incs 15X15IN Opth LF Strl
5manufacturers in China registered for this device type
3catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (2), Zhejiang (1), Shanghai (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| GRI Medical & Electronic Technology Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 71 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Shanghai Dochem Industries Co., Ltd. | Shanghai | Shanghai | Manufacturer | 45 |
| Jiangsu Medplus NON-Woven Manufacturer Co., Ltd. | Siyang | Jiangsu | Manufacturer | 21 |
| Jilin Test BIO-Electron Co., Ltd. | Changchun | Jilin | Manufacturer | 9 |
Record
| Listed by | Resource Optimization & Innovation, L.L.C. |
|---|---|
| FDA product code | HMT |
| Device type | Drape, Patient, Ophthalmic |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4370 |
| Premarket notification | Exempt |
| Record published | 2023-12-20 |
| Record revised | 2026-05-01 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Over the counter | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 4, pack of 10, pack of 20 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DRP1-15X15ST-REG | In distribution | |
| DRP1-31X51ST-REG | In distribution | |
| DRP1-51X50ST-REG | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Atlanta Healthcare Services OcuDrape® | Atlanta Healthcare Services | 80 |
| Convertors | Cardinal Health 200, LLC | 70 |
| Alcon Eye-Pak | Alcon Laboratories, Inc. | 36 |
| PRO-Paks®️ | Microspecialities, Inc. | 14 |
| Alcon Viseo | Alcon Laboratories, Inc. | 8 |
| Drape, Patient, Ophthalmic | Eagle Labs, LLC | 8 |
| Unity | Alcon Laboratories, Inc. | 3 |
| Avid TruCustom | Avid Medical, Inc. | 2 |
| Medline | Medline Industries, Inc. | 2 |
| SurgiCube drape | Toul Meditech AB | 1 |
| Alcon | Alcon Laboratories, Inc. | 1 |
| Medline Industries, Inc. | Medline Industries, 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.