Anodyne Surgical
Irrigating Cystotome [Joyce] 25g X 16mm (5/8"), curved
2manufacturers in China registered for this device type
106catalogue 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 | Psi/Eye-Ko, Inc. |
|---|---|
| FDA product code | HNY |
| Device type | Cystotome |
| Device class | Class 1 |
| Regulation | 21 CFR 886.4350 |
| Premarket notification | Exempt |
| Record published | 2023-06-14 |
| Record revised | 2025-04-07 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Radiation Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Bag of 50, bag of 500, box of 10, box of 100 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 5003AC | 10 | In distribution | |
| 5003AF.2 | 10 | In distribution | |
| 5003AF.2 | 100 | In distribution | |
| 5003AF | 100 | In distribution | |
| 5008 | 100 | In distribution | |
| 5000AF | 100 | In distribution | |
| 5008S | 100 | In distribution | |
| 5003CS | In distribution | ||
| 5001AC | 10 | In distribution | |
| 5003CS | 100 | In distribution | |
| 5003AA | 100 | In distribution | |
| 5003ASC | 100 | In distribution | |
| 5007 | 10 | In distribution | |
| 5003ASC | 10 | In distribution | |
| 5001AC | 100 | In distribution | |
| 5001AF.2 | 100 | In distribution | |
| 5001AC | In distribution | ||
| 5004AF | 100 | In distribution | |
| 5003AS | In distribution | ||
| 5003AS | 10 | In distribution | |
| 5003AA | 10 | In distribution | |
| 5003CF.1 | In distribution | ||
| 5001ARF | In distribution | ||
| 5001AF | In distribution | ||
| 5007S | 10 | In distribution | |
| 5003AS | 100 | In distribution | |
| 5003ARF | 10 | In distribution | |
| 5001AS | 10 | In distribution | |
| 5003CF.1 | 10 | In distribution | |
| 5008S | In distribution | ||
| 5003AA | In distribution | ||
| 5000AS | 10 | In distribution | |
| 5012 | In distribution | ||
| 5003AF.5 | In distribution | ||
| 5003AAT | In distribution | ||
| 5003AF.6 | 100 | In distribution | |
| 5009 | 100 | In distribution | |
| 5009S | 10 | In distribution | |
| 5003AF.3 | In distribution | ||
| 5003ASR | 10 | In distribution | |
| 5010 | 100 | In distribution | |
| 5003ASC | In distribution | ||
| 5003AF | 10 | In distribution | |
| 5003AF | In distribution | ||
| 5004AF | 10 | In distribution | |
| 5001ARF | 10 | In distribution | |
| 5003AFB | In distribution | ||
| 5009S | 100 | In distribution | |
| 5001AA | 100 | In distribution | |
| 5007 | 100 | In distribution | |
| 5007 | In distribution | ||
| 5003ASR | In distribution | ||
| 5010 | 10 | In distribution | |
| 5009 | 10 | In distribution | |
| 5003AC | 100 | In distribution | |
| 5003CF | 100 | In distribution | |
| 5007S | 100 | In distribution | |
| 5001AS | 100 | In distribution | |
| 5001ARF | 100 | In distribution | |
| 5003CF | In distribution | ||
| 5004AS | 100 | In distribution | |
| 5003AF.6 | In distribution | ||
| 5007S | In distribution | ||
| 5003AAB | In distribution | ||
| 5003AAB | 100 | In distribution | |
| 5004AS | In distribution | ||
| 5003ASR | 100 | In distribution | |
| 5008 | 10 | In distribution | |
| 5001ASR | 100 | In distribution | |
| 5008 | In distribution | ||
| 5003CF.1 | 100 | In distribution | |
| 5003AAB | 10 | In distribution | |
| 5000AF | In distribution | ||
| 5003CF | 10 | In distribution | |
| 5003ARF | 100 | In distribution | |
| 5012 | 10 | In distribution | |
| 5000AS | 100 | In distribution | |
| 5003AC | In distribution | ||
| 5003AAT | 100 | In distribution | |
| 5008S | 10 | In distribution | |
| 5003ARF | In distribution | ||
| 5003AF.2 | In distribution | ||
| 5010 | In distribution | ||
| 5009S | In distribution | ||
| 5009 | In distribution | ||
| 5001ASR | 10 | In distribution | |
| 5000AS | In distribution | ||
| 5000AF | 10 | In distribution | |
| 5001AA | In distribution | ||
| 5003AF.5 | 100 | In distribution | |
| 5003AF.3 | 100 | In distribution | |
| 5003CS | 10 | In distribution | |
| 5001AF.2 | 10 | In distribution | |
| 5001AF | 100 | In distribution | |
| 5003AAT | 10 | In distribution | |
| 5001ASR | In distribution | ||
| 5003AF.5 | 10 | In distribution | |
| 5003AF.6 | 10 | In distribution | |
| 5001AF.2 | In distribution | ||
| 5001AA | 10 | In distribution | |
| 5004AF | In distribution | ||
| 5001AS | In distribution | ||
| 5004AS | 10 | In distribution | |
| 5003AF.3 | 10 | In distribution | |
| 5001AF | 10 | In distribution | |
| 5004BFT | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| Alcon | Alcon Laboratories, Inc. | 16 |
| 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.