Irrigating Cystotome
11 catalogue numbers from 3525, listed by Hurricane Medical, United States, under Cystotome. 2 manufacturers in China are registered for this product code.
2manufacturers in China registered for this device type
11catalogue 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 | Hurricane Medical, United States |
|---|---|
| FDA product code | HNY |
| Device type | Cystotome |
| Device class | Class 1 |
| Regulation | 21 CFR 886.4350 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-01-23 |
| Record revised | 2020-04-08 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide, Radiation Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Sizes | Needle gauge 23 to 30 G; length 16 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 3525 | Needle Gauge 25 G | 10 | In distribution |
| 3530 | Needle Gauge 30 G | 10 | In distribution |
| 3030 | Length 16 mm | 10 | In distribution |
| 3925 | Needle Gauge 25 G | 10 | In distribution |
| 3225 | Length 16 mm | 10 | In distribution |
| 3523 | Needle Gauge 23 G | 10 | In distribution |
| 3927 | Needle Gauge 27 G | 10 | In distribution |
| 3227 | Needle Gauge 27 G | 10 | In distribution |
| 3023 | Length 16 mm | 10 | In distribution |
| 3027 | Length 16 mm | 10 | In distribution |
| 3527 | Length 16 mm | 10 | In distribution |
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 |
| Alcon | Alcon Laboratories, Inc. | 16 |
| Blink | Katena Products, Inc. | 14 |
| 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.