Anodyne Surgical
Anodyne Forsight Kit AFK-0001
3manufacturers in China registered for this device type
7catalogue 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 | Psi/Eye-Ko, Inc. |
|---|---|
| FDA product code | PZG |
| Device type | Surgical Eye Tray |
| Device class | Class 1 |
| Regulation | 21 CFR 886.4350 |
| Premarket notification | Exempt |
| Record published | 2024-04-26 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Radiation Sterilization, Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AFK-0001 | In distribution | |
| AFK-0002 | In distribution | |
| AFK-0006 | In distribution | |
| AFK-0007 | In distribution | |
| AFK-0005 | In distribution | |
| AFK-0004 | In distribution | |
| AFK-0003 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Readypak | Beaver-Visitec International, Ltd | 72 |
| Stradis Healthcare | Stradis Healthcare | 49 |
| Stradis | Stradis Healthcare | 17 |
| Kaiser Permanente Kit Pack | Oasis Medical, Inc. | 16 |
| Surgeon’s Choice Card | Oasis Medical, Inc. | 16 |
| CustomEyes® | Beaver-Visitec International, Ltd | 9 |
| 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.