Ambler Surgical
Irrigating cystotome, 30 gauge x 5/8'', straight, packaged individually, sterile, disposable, box of 10 * * SPECIAL ORDER PRODUCT - MINIMUM ORDER OF 20 BOXES AND 4-6 WEEK LEAD TIME * * * *…
Irrigating cystotome, 30 gauge x 5/8”, straight, packaged individually, sterile, disposable, box of 10 * * SPECIAL ORDER PRODUCT – MINIMUM ORDER OF 20 BOXES AND 4-6 WEEK LEAD TIME * * * * SPECIAL ORDER PRODUCT – MINIMUM ORDER OF 20 BOXES AND 4-6 WEEK LEAD TIME * *
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 | Ambler Surgical, LLC, United States |
|---|---|
| FDA product code | HNY |
| Device type | Cystotome |
| Device class | Class 1 |
| Regulation | 21 CFR 886.4350 |
| Establishment | Repacker / relabeller |
| Premarket notification | Exempt |
| Record published | 2021-01-04 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Box of 10 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Irrigating cystotome | In distribution | |
| Irrigating cystotome | In distribution | |
| Irrigating cystotome | In distribution | |
| Irrigating cystotome | In distribution | |
| Cystotome cannula | In distribution | |
| Cystotome cannula | In distribution | |
| Kratz cystotome cannula | In distribution | |
| Drews cystotome cannula | In distribution | |
| Knolle-Kelman cystotome cannula | In distribution | |
| Kelman cystotome knife cannula | In distribution | |
| Irrigating cystotome | In distribution | |
| Irrigating cystotome | In distribution | |
| McIntyre cystotome cannula | In distribution | |
| Irrigating cystotome | In distribution | |
| Maumenee goniotomy knife cannula | In distribution | |
| Irrigating cystotome | In distribution | |
| Cystotome cannula | In distribution | |
| Irrigating cystotome | In distribution | |
| Drews cystotome cannula | In distribution | |
| Irrigating cystotome | In distribution | |
| Kelman cystotome knife cannula | In distribution | |
| Kelman cystotome knife cannula | In distribution | |
| Irrigating cystotome | In distribution | |
| Lieppman cystotome cannula | In distribution | |
| Irrigating cystotome | 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 |
| 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.