Clip, Iris Retractor
Disposable Polypropylene Iris Retractors
3manufacturers in China registered for this device type
5catalogue 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 | Microvision, Inc., 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 | 2018-04-04 |
| Record revised | 2018-06-11 (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 30, carton of 20 |
| Sizes | Length 9 mm |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| N/A | Length 9.0 mm | 5 | In distribution |
| N/A | Length 9.0 mm | 6 | In distribution |
| N/A | Length 9.0 mm | 4 | In distribution |
| N/A | Length 9.0 mm | 5 | In distribution |
| N/A | Length 9.0 mm | 4 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Clip, Iris Retractor | Optalmed, LLC. | 10 |
| Iris Retractor | Katena Products, Inc. | 9 |
| 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.