Aesculap
STOCKMANN Penis Clamp, 2 3/4", (70 mm), non-sterile, reusable
3manufacturers in China registered for this device type
1catalogue number
1recall
Who Else Makes It
Concentrated in Shanghai (1), Jiangsu (1), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Touchstone International Medical Science Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 5 |
| Shen Zhen Great Force Plastic Products Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 1 |
Record
| Listed by | Aesculap AG, Germany |
|---|---|
| FDA product code | FHA |
| Device type | Clamp, Penile |
| Device class | Class 1 |
| Regulation | 21 CFR 876.5160 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2020-04-20 |
| Record revised | 2021-07-20 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| EF400R | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Greenwald Surgical Company, Inc. | Grace Manufacturing Inc | 11 |
| MSI Precision Specialty Instruments | MED Saver, Inc. | 6 |
| KindKlamp | Argentum Medical, LLC | 4 |
| V. Mueller | Steris Corporation | 3 |
| Incontinence Clamp | C.R. Bard, Inc. | 3 |
| Symmetry Surgical | Aspen Surgical Products, Inc. | 2 |
| Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 2 |
| Penile Clamp | C.R. Bard, Inc. | 2 |
| RZ Medizintechnik GmbH | RZ Medizintechnik Gmbh | 2 |
| Jeato 7 Incontinence Clamp | Jeato MED Co., Ltd. | 1 |
| Novo Surgical | Novo Surgical, Inc. | 1 |
| Gimmi | Gimmi Gmbh | 1 |
Showing 12 of 22. All products under Clamp, Penile
Recalls
1 of these is Class III. Class III is unlikely to cause harm at all → typically a labelling or documentation fault. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Closed |
|---|---|---|---|---|
| 2018-02-16 | Class III | Mixed-up of materials/components | The plastic sleeves of the Penis Clamp and Mouth Gag may stick together during or after reprocessing rendering the instruments unusable. | 2020-06-30 |
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.