Disposable Instruments
Capsulorhexis Cystotome, Formed, 27g x 5/8” (0.4 x 16mm), 90 degree Tip, Non-Sterile
2manufacturers in China registered for this device type
26catalogue 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 | Oasis Medical, 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, Exporter |
| Premarket notification | Exempt |
| Record published | 2023-05-30 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Radiation Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Packaging | Carton of 10, plastic bag of 100 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| B-4017L-NS | 100 | In distribution | |
| B-4017L-NSC | 100 | In distribution | |
| B-4017G-NSC | 1,000 | In distribution | |
| B-4017IO-NSC | 1,000 | In distribution | |
| 4017G, B-4017G | In distribution | ||
| B-4017M-NS | 100 | In distribution | |
| 4017I, B-4017I | In distribution | ||
| 4017X, B-4017X | In distribution | ||
| B-4017M-NSC | 1,000 | In distribution | |
| 4017IE, B-4017IE | In distribution | ||
| 4017R, B-4017R | In distribution | ||
| 4017B, B-4017B | In distribution | ||
| 4017N, B-4017N | In distribution | ||
| 4017IS, B-4017IS | In distribution | ||
| 4017L → B-4017L | In distribution | ||
| B-4017N-NSC | 1,000 | In distribution | |
| 4017Y | In distribution | ||
| 4017M, B-4017M | In distribution | ||
| B-4017IE-NSC | 1,000 | In distribution | |
| B-4017R-NSC | 1,000 | In distribution | |
| 4017A, B-4017A | In distribution | ||
| 4017, B-4017 | In distribution | ||
| 4017IO, B-4017IO | In distribution | ||
| 4017S, B-4017S | In distribution | ||
| 4017Z | In distribution | ||
| B-4017G-NS | 100 | 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 |
| 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.