Maxiris Flexible Iris Retractor PACK/5
Catalogue number AS-9255, listed by Katena Products, Inc., United States, under Clip, Iris Retractor. 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Shanghai (1), Shandong (1), Jiangsu (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Sihong Ophsurin Co., Ltd. | Suqian | Jiangsu | Manufacturer | 17 |
Record
| Listed by | Katena Products, Inc., United States |
|---|---|
| FDA product code | HOC |
| Device type | Clip, Iris Retractor |
| 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 | 2022-12-13 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| AS-9255 | 5 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Clip, Iris Retractor | Optalmed, LLC. | 10 |
| Iris Retractor | Katena Products, Inc. | 9 |
| Clip, Iris Retractor | Microvision, Inc. | 5 |
| Malyugin Ring System 6.25mm | Microsurgical Technology, Inc. | 4 |
| MSI Precision Specialty Instruments | MED Saver, Inc. | 2 |
| Malyugin Ring System 2.0, 7.0mm | Microsurgical Technology, Inc. | 2 |
| Clip, Iris Retractor | Geuder Aktiengesellschaft | 2 |
| Malyugin Ring System 7.0mm | Microsurgical Technology, Inc. | 2 |
| Malyugin Ring System 2.0, 6.25mm | Microsurgical Technology, Inc. | 2 |
| Xpand | Diamatrix | 2 |
| Disposable Iris Retract | Katena Products, Inc. | 2 |
| Alcon Grieshaber | Alcon Laboratories, Inc. | 2 |
Showing 12 of 28. All products under Clip, Iris Retractor
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.