Surgeon’s Choice Card
Kit Packs Assembled from Non-Sterile Capped Product 1 eaches of Irrigating Cystotome, Angled, 25g x 5/8" (0.5 x 16mm) (GTIN: 00845819001493) 1 eaches of Cortical Cleaving Hydrodissector,…
Kit Packs Assembled from Non-Sterile Capped Product 1 eaches of Irrigating Cystotome, Angled, 25g x 5/8″ (0.5 x 16mm) (GTIN: 00845819001493) 1 eaches of Cortical Cleaving Hydrodissector, 27g x 7/8″ (0.4 x 22mm), 11mm Bend, Round End (GTIN: 00845819005958) 1 eaches of Cortical Cleaving Hydrodissector, 27g x 7/8″ (0.4 x 22mm), Flat End, 11mm Bend (GTIN: 00845819005354) 1 eaches of Sideport Knives, Safety Line (GTIN: 00845819005989) 1 eaches of Thin Slit, Safety Line (Single Bevel Blade) (GTIN: 00845819005903)
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 | Oasis Medical, Inc., United States |
|---|---|
| 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, Exporter |
| Premarket notification | Exempt |
| Record published | 2023-06-30 |
| Record revised | 2025-01-14 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Radiation Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Packaging | Carton of 20, carton of 12 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SCK 2005, B-SCK 2005 | In distribution | |
| SCK 2001, B-SCK 2001 | In distribution | |
| SCK 2000, B-SCK 2000 | In distribution | |
| SCK-2012, B-SCK-2012 | In distribution | |
| SCK 2009, B-SCK 2009 | In distribution | |
| SCK 1001, B-SCK 1001 | In distribution | |
| SCK 2006, B-SCK 2006 | In distribution | |
| B-SCK 2011 | In distribution | |
| SCK 2011 | In distribution | |
| SCK 1000, B-SCK 1000 | In distribution | |
| SCK 2002, B-SCK 2002 | In distribution | |
| SCK 2004, B-SCK 2004 | In distribution | |
| SCK 2008, B-SCK 2008 | In distribution | |
| SCK 2007, B-SCK 2007 | In distribution | |
| SCK 2009, B-SCK 2009 | In distribution | |
| SCK 2003, B-SCK 2003 | 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 |
| 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.