Alcon
Microsurgical Instrument IRR. CYSTITSOME 25GA FORMED REVERSE CUT SHORT RADIUS
2manufacturers in China registered for this device type
16catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (1), Shandong (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 |
Record
| Listed by | Alcon Laboratories, Inc., United States |
|---|---|
| FDA product code | HNY |
| Device type | Cystotome |
| Device class | Class 1 |
| Regulation | 21 CFR 886.4350 |
| Premarket notification | Exempt |
| Record published | 2020-08-18 |
| Record revised | 2024-03-22 (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, manufacturing date |
| Packaging | Pack of 10 |
| Distribution end date | 2023-12-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 8065426220 | In distribution | |
| 8065426020 | In distribution | |
| 8065425820 | In distribution | |
| 8065421020 | In distribution | |
| 8065425520 | In distribution | |
| 8065426620 | In distribution | |
| 8065424620 | In distribution | |
| 8065425120 | In distribution | |
| 8065446520 | In distribution | |
| 8065425320 | In distribution | |
| 8065426320 | Withdrawn | |
| 8065425920 | Withdrawn | |
| 8065424720 | Withdrawn | |
| 8065420920 | Withdrawn | |
| 8065420620 | Withdrawn | |
| 8065445520 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Anodyne Surgical | Psi/Eye-Ko, Inc. | 106 |
| MSI Precision Specialty Instruments | MED Saver, Inc. | 32 |
| Visitec® | Beaver-Visitec International, Ltd | 32 |
| Walcott Rx Products | Psi/Eye-Ko, Inc. | 30 |
| Disposable Instruments | Oasis Medical, Inc. | 26 |
| Ambler Surgical | Ambler Surgical, LLC | 25 |
| Blink | Katena Products, Inc. | 14 |
| Irrigating Cystotome | Hurricane Medical | 11 |
| Oph. Cystotomes | Katena Products, Inc. | 9 |
| Millennium | Avalign Technologies, Inc. | 6 |
| Cystotome | Katena Products, Inc. | 6 |
| V. Mueller | Steris Corporation | 4 |
Showing 12 of 45. All products under Cystotome
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.