V. Mueller
V. Mueller SUPER SHARP BLADE DISP KNIFE #75-31 BLK
8manufacturers in China registered for this device type
2catalogue numbers in this listing
1recall
Who Else Makes It
Concentrated in Zhejiang (2), Guangdong (2), Shanghai (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 |
| Nanjing J SUN Healthcare Co., Ltd. | Nanjing | Jiangsu | Repacker / relabeller | 56 |
| Hangzhou Kangji Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 27 |
| Bothwin (Beijing) Medical Technology Co., Ltd. | Beijng | Beijing | Manufacturer | 25 |
| Hangzhou Tonglu Shikonghou Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 17 |
| Foshan Cicada Dental Instrument Co., Ltd. | Foshan | Guangdong | Manufacturer | 15 |
| Shenzhen Soga Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 7 |
Record
| Listed by | Carefusion 2200, Inc., United States |
|---|---|
| FDA product code | EMF |
| Device type | Knife, Surgical |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-09-05 |
| Record revised | 2022-05-20 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Packaging | Box of 10, pack of 6 |
| Distribution end date | 2019-02-12 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| OP07531 | Withdrawn | |
| OP0700-07 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Surgistar | Surgistar, Inc. | 285 |
| Surtex | Surtex Instruments Ltd | 189 |
| HU-Friedy | HU-Friedy MFG Co., LLC | 80 |
| Zoll-Dental | Zoll-Dental | 72 |
| Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 59 |
| Lazic | Peter Lazic Gmbh | 47 |
| Millennium | Avalign Technologies, Inc. | 40 |
| Aesculap | Aesculap AG | 38 |
| Sklar | Sklar Corporation | 35 |
| Stylus | Surgical Specialties México, S. de R.L. de C.V. | 32 |
| V. Mueller | Steris Corporation | 31 |
| Elmed | Elmed, Inc. | 30 |
Showing 12 of 122. All products under Knife, Surgical
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2020-05-18 | Class II | Under Investigation by firm | Becton Dickinson and Company, is conducting a voluntary recall on the V. MuellerTM 3H Knife Handles catalog number listed in the table above. BD has been informed by our supplier that the external threads on some of the collets (Figure 1) c | 358 units | 2021-04-25 |
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.