Clip, Iris Retractor
Disposable Flat Iris Retractors, 6 sets of 5 retractors
3manufacturers in China registered for this device type
10catalogue numbers in this listing
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 | Optalmed, LLC., United States |
|---|---|
| FDA product code | HOC |
| Device type | Clip, Iris Retractor |
| Device class | Class 1 |
| Regulation | 21 CFR 886.4350 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2021-03-10 |
| Record revised | 2025-08-21 (version 2) |
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 |
| Storage | Special storage condition: Caution; Special storage condition: Keep dry; Special storage condition: Keep away from direct sunlight |
| Packaging | Carton of 6, carton of 5 |
| Distribution end date | 2025-08-20 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| Rx5213 | 5 | In distribution | |
| 7013 | 5 | In distribution | |
| Rx5127 | 6 | In distribution | |
| 7003 | 6 | In distribution | |
| Rx5067B-5 | 5 | In distribution | |
| 7002 | 5 | In distribution | |
| 7001 | 5 | In distribution | |
| 7004 | 5 | In distribution | |
| 30-254 | 6 | Withdrawn | |
| 30-134-6 | 5 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| Maxiris Flexible Iris Retractor PACK/5 | Katena Products, Inc. | 1 |
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.