Kaiser Permanente Kit Pack
Procedure Packs Assembled from Non-Sterile Capped (NSC) Product 1 eaches of Hydrodissection Cannula, 27g x 3/4”, 1mm Bend (GTIN: 00845819001530) 1 eaches of A/C Washout Cannula, 19g x 1",…
Procedure Packs Assembled from Non-Sterile Capped (NSC) Product 1 eaches of Hydrodissection Cannula, 27g x 3/4”, 1mm Bend (GTIN: 00845819001530) 1 eaches of A/C Washout Cannula, 19g x 1″, 8mm Bend, Flattened (GTIN: 00845819001592) 1 eaches of Anterior Chamber Cannula, 27g x 7/8″, 4mm Bend (GTIN: 00845819001455) 1 eaches of Anterior Chamber Cannula, 27g x 7/8″, 8mm Bend (GTIN: 00845819001448) 1 eaches of Irrigating Cystotome, Formed, 25g x 5/8″ (GTIN: 00845819001479)
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 |
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, pack of 20 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| KP-4701-SP, B-KP-4701-SP | In distribution | |
| KP-4705-SP, B-KP-4705-SP | In distribution | |
| KP-4716-SP, B-KP-4716-SP | In distribution | |
| KP-4707-SP, B-KP-4707-SP | In distribution | |
| KP-4708-SP, B-KP-4708-SP | In distribution | |
| KP-4704-SP, B-KP-4704-SP | In distribution | |
| KP-4710-SP, B-KP-4710-SP | In distribution | |
| KP-4706-SP, B-KP-4706-SP | In distribution | |
| KP-4715-SP, B-KP-4715-SP | In distribution | |
| KP-4713-SP, B-KP-4713-SP | In distribution | |
| KP-4714-SP, B-KP-4714-SP | In distribution | |
| KP-4703-SP, B-KP-4703-SP | In distribution | |
| KP-4711-SP, B-KP-4711-SP | In distribution | |
| KP-4702-SP, B-KP-4702-SP | In distribution | |
| KP-4709-SP, B-KP-4709-SP | In distribution | |
| KP-4712-SP, B-KP-4712-SP | 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 |
| 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.