Stradis
Custom Convenience KIT, Ophthalmic, Microsurgical
3manufacturers in China registered for this device type
17catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (1), Hubei (1), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Malosa Medical Instruments (Changshu) Limited | Changshu | Jiangsu | Contract manufacturer | 24 |
| GRI Medical & Electronic Technology Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 71 |
| Hubei Lanbin Medical Group Co., Ltd. | Xiaogan | Hubei | Contract manufacturer | 33 |
Record
| Listed by | Stradis Healthcare, United States |
|---|---|
| FDA product code | PZG |
| Device type | Surgical Eye Tray |
| Device class | Class 1 |
| Regulation | 21 CFR 886.4350 |
| Premarket notification | Exempt |
| Record published | 2016-05-05 |
| Record revised | 2022-06-17 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Packaging | Pack of 20, pack of 10 |
| Distribution end date | 2023-02-07 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 687-550 | In distribution | |
| 689-161B | In distribution | |
| 689-228 | Withdrawn | |
| 689-300 | Withdrawn | |
| 689-382 | Withdrawn | |
| 689-161B | Withdrawn | |
| 689-162 | Withdrawn | |
| 689-273 | Withdrawn | |
| 689-161A | Withdrawn | |
| 689-276 R1 | Withdrawn | |
| 687-069 | Withdrawn | |
| 687-093 | Withdrawn | |
| 689-252R3 | Withdrawn | |
| 689-273 | Withdrawn | |
| 689-161A | Withdrawn | |
| 687-395 | Withdrawn | |
| 689-382R1 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Readypak | Beaver-Visitec International, Ltd | 72 |
| Stradis Healthcare | Stradis Healthcare | 49 |
| Kaiser Permanente Kit Pack | Oasis Medical, Inc. | 16 |
| Surgeon’s Choice Card | Oasis Medical, Inc. | 16 |
| CustomEyes® | Beaver-Visitec International, Ltd | 9 |
| Anodyne Surgical | Psi/Eye-Ko, Inc. | 7 |
| Beaver-Visitec | Beaver-Visitec International, Ltd | 6 |
| Invenio | GRI Medical & Electronic Technology Co., Ltd. | 3 |
| Stockton Kit 2 | Blink Medical Ltd | 2 |
| Cataract Inst Set – Spokane Anderson | Blink Medical Ltd | 2 |
| Sub Tenon Set – Fine Tip | Blink Medical Ltd | 2 |
| Stockton Kit 1 | Blink Medical Ltd | 2 |
Showing 12 of 79. All products under Surgical Eye Tray
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.