Avid TruCustom
2 catalogue numbers from AV011233_0002, listed by Avid Medical, Inc., United States, under Drape, Patient, Ophthalmic. 5 manufacturers in China are registered for this product code.
5manufacturers in China registered for this device type
2catalogue 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 | Avid Medical, Inc., United States |
|---|---|
| FDA product code | HMT |
| Device type | Drape, Patient, Ophthalmic |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4370 |
| Premarket notification | Exempt |
| Record published | 2016-09-09 |
| Record revised | 2024-06-24 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 50, pack of 13 |
| Distribution end date | 2024-06-21 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AV011233_0002 | Withdrawn | |
| OPTH006_0001 | Withdrawn |
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 |
| Regard™ | Resource Optimization & Innovation, L.L.C. | 3 |
| Unity | Alcon Laboratories, Inc. | 3 |
| 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.