PRO-Paks®️
Drape Ophthalmic, 3-sided Gutter Pouch, Incise, Non-woven with Plastic head. Made from high quality fabric and finishes providing our customers with an enhanced experience while using our…
Drape Ophthalmic, 3-sided Gutter Pouch, Incise, Non-woven with Plastic head. Made from high quality fabric and finishes providing our customers with an enhanced experience while using our drapes. 10 per bag.
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 | Microspecialities, Inc. |
|---|---|
| FDA product code | HMT |
| Device type | Drape, Patient, Ophthalmic |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4370 |
| Premarket notification | Exempt |
| Record published | 2018-10-30 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Box of 10, box of 20 |
| Sizes | Length 1.905 to 254 cm; width 10.16 to 180.34 cm; length 0.75 to 100 in; width 4 to 71 in |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PD831 | Length 180.34 cm | In distribution |
| PD851 | Length 254 cm | In distribution |
| PD1060 | Length 129.54 cm | In distribution |
| PD801 | Width 48 in | In distribution |
| PD350 | Length 1.905 cm | In distribution |
| PD320 | Width 16 in | In distribution |
| PD352 | Width 5.25 in | In distribution |
| PD850A | Width 71 in | In distribution |
| PD360 | Length 24.765 cm | In distribution |
| PD1176 | Length 203.2 cm | In distribution |
| PD1022 | Length 27.178 cm | In distribution |
| PD1059A | Width 48 in | In distribution |
| PD1061 | Width 48 in | In distribution |
| PD117 | Width 65 in | 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 |
| Alcon Viseo | Alcon Laboratories, Inc. | 8 |
| Drape, Patient, Ophthalmic | Eagle Labs, LLC | 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.