Drape, Patient, Ophthalmic
Medium plastic drape, 48" x 51" (122cm x 130cm), with adhesive incise and fluid collection
5manufacturers in China registered for this device type
8catalogue 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 | Eagle Labs, LLC, United States |
|---|---|
| FDA product code | HMT |
| Device type | Drape, Patient, Ophthalmic |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4370 |
| Establishment | Contract manufacturer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-10-28 |
| Record revised | 2018-03-29 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Carton of 5, carton of 10 |
| Sizes | Area/surface area 171.2 to 2448 Square inch |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 810-54 | In distribution | |
| 810-64 | In distribution | |
| 810-20 | Area/Surface Area 256 Square inch | In distribution |
| 810-30 | Area/Surface Area 1600 Square inch | In distribution |
| 810-61 | Area/Surface Area 2448 Square inch | In distribution |
| 810-22 | Area/Surface Area 171.2 Square inch | In distribution |
| 810-60 | Area/Surface Area 2400 Square inch | In distribution |
| 810-21 | Area/Surface Area 256 Square inch | 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 |
| Regard™ | Resource Optimization & Innovation, L.L.C. | 3 |
| 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.