Visitec®
High Viscosity Injector 4MM 16CM Tube (5/SP)
2manufacturers in China registered for this device type
1catalogue number
1recall
Who Else Makes It
Concentrated in Jiangsu (1), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Sihong Ophsurin Co., Ltd. | Suqian | Jiangsu | Manufacturer | 17 |
| Shenzhen Create Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 9 |
Record
| Listed by | Beaver-Visitec International, Ltd, United Kingdom |
|---|---|
| FDA product code | KYG |
| Device type | Device, Irrigation, Ocular Surgery |
| Device class | Class 1 |
| Regulation | 21 CFR 886.4360 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2021-12-03 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 585208 | 5 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Ambler Surgical | Ambler Surgical, LLC | 137 |
| Rumex | Rumex International Co. | 20 |
| Anodyne Surgical | Psi/Eye-Ko, Inc. | 17 |
| Device, Irrigation, Ocular Surgery | Geuder Aktiengesellschaft | 17 |
| High pressure injection/aspiration system for syringe – Connector A | Aktive SRL | 16 |
| Phaco Accessory Set | Medicel AG | 14 |
| MSI Precision Specialty Instruments | MED Saver, Inc. | 11 |
| Bausch + Lomb | Bausch & Lomb Incorporated | 9 |
| High pressure injection/aspiration system with syringe – Connector E | Aktive SRL | 8 |
| Medetz Surgical Instruments | Medetz Surgical Instruments | 7 |
| Device, Irrigation, Ocular Surgery | Microvision, Inc. | 3 |
| MorTan | Zien Medical Technologies LLC | 3 |
Showing 12 of 114. All products under Device, Irrigation, Ocular Surgery
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2007-03-02 | Not classified | Other | Mislabeled: Carton label incorrectly labeled as Ref 581618 (.40 X 16mm) , may contain product Ref 581617 (.50 x 16mm) | 1500 units | 2008-03-05 |
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.