Readypak
Custom Readypak #584089 (1/EA)
3manufacturers in China registered for this device type
72catalogue numbers in this listing
6recalls on this code
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 | Beaver-Visitec International, Ltd, United Kingdom |
|---|---|
| FDA product code | PZG |
| Device type | Surgical Eye Tray |
| Device class | Class 1 |
| Regulation | 21 CFR 886.4350 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-06-27 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Radiation Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Store in a dry place. |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 58000601 | In distribution | |
| 584838 | In distribution | |
| 584846 | In distribution | |
| 584825 | In distribution | |
| 584854 | In distribution | |
| 58000089 | In distribution | |
| 58000783 | In distribution | |
| 583813 | In distribution | |
| 58000609 | In distribution | |
| 58000156 | In distribution | |
| 584961 | In distribution | |
| 584922 | In distribution | |
| 584089 | In distribution | |
| 583926 | In distribution | |
| 584999 | In distribution | |
| 58000090 | In distribution | |
| 584940 | In distribution | |
| 583909 | In distribution | |
| 584007 | In distribution | |
| 58000113 | In distribution | |
| 584949 | In distribution | |
| 584088 | In distribution | |
| 584895 | In distribution | |
| 58000130 | In distribution | |
| 584888 | In distribution | |
| 584997 | In distribution | |
| 584852 | In distribution | |
| 584843 | In distribution | |
| 58000131 | In distribution | |
| 584936 | In distribution | |
| 584822 | In distribution | |
| 584884 | In distribution | |
| 584971 | In distribution | |
| 583922 | In distribution | |
| 583928 | In distribution | |
| 58000073 | In distribution | |
| 584845 | In distribution | |
| 584933 | In distribution | |
| 584863 | In distribution | |
| 583904 | In distribution | |
| 584824 | In distribution | |
| 58000220 | In distribution | |
| 58000173 | In distribution | |
| 58000129 | In distribution | |
| 58000098 | In distribution | |
| 58000187 | In distribution | |
| 584839 | In distribution | |
| 58000132 | In distribution | |
| 584939 | In distribution | |
| 583840 | In distribution | |
| 584934 | In distribution | |
| 58000216 | In distribution | |
| 584952 | In distribution | |
| 58000602 | In distribution | |
| 584842 | In distribution | |
| 584886 | In distribution | |
| 584935 | In distribution | |
| 583865 | In distribution | |
| 584823 | In distribution | |
| 58000095 | In distribution | |
| 584998 | In distribution | |
| 58000074 | In distribution | |
| 584983 | In distribution | |
| 584844 | In distribution | |
| 58000117 | In distribution | |
| 58000558 | In distribution | |
| 584880 | In distribution | |
| 584938 | In distribution | |
| 584084 | In distribution | |
| 583896 | In distribution | |
| 584937 | In distribution | |
| 58000186 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| 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
Recalls
6 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2021-11-17 | Class II | Packaging change control | Kit packaging may have small holes compromising product sterility | 920 units |
| 2021-11-17 | Class II | Packaging change control | Kit packaging may have small holes compromising product sterility | 1170 units |
| 2021-11-17 | Class II | Packaging change control | Kit packaging may have small holes compromising product sterility | 30 units |
| 2021-11-17 | Class II | Packaging change control | Kit packaging may have small holes compromising product sterility | 680 units |
| 2021-11-17 | Class II | Packaging change control | Kit packaging may have small holes compromising product sterility | 120 units |
| 2021-11-17 | Class II | Packaging change control | Kit packaging may have small holes compromising product sterility | 380 units |
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.