Oph. Cystotomes
Cystotome Reversed Form 25GA
2manufacturers in China registered for this device type
9catalogue 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 | Katena Products, Inc., United States |
|---|---|
| FDA product code | HNY |
| Device type | Cystotome |
| Device class | Class 1 |
| Regulation | 21 CFR 886.4350 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-09-14 |
| Record revised | 2022-12-15 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Radiation Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Sizes | Needle gauge 23 to 27 G; length 12 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| K20-3076 | Needle Gauge 27 G | 10 | In distribution |
| K20-3062 | Length 12 mm | 10 | In distribution |
| K20-3072 | Needle Gauge 27 G | 10 | In distribution |
| K20-3056 | Needle Gauge 25 G | 10 | In distribution |
| K20-3070 | Needle Gauge 25 G | 10 | In distribution |
| K20-3057 | Needle Gauge 27 G | 10 | In distribution |
| K20-3066 | Length 12 mm | 10 | In distribution |
| K20-3074 | Needle Gauge 25 G | 10 | In distribution |
| K20-3068 | Needle Gauge 23 G | 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 |
| Irrigating Cystotome | Hurricane Medical | 11 |
| 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.