Greenwald Surgical Company, Inc.
Baumrucker incontinence clamp, Juvenile
3manufacturers in China registered for this device type
11catalogue numbers in this listing
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 | Grace Manufacturing Inc, United States |
|---|---|
| FDA product code | FHA |
| Device type | Clamp, Penile |
| Device class | Class 1 |
| Regulation | 21 CFR 876.5160 |
| Establishment | Contract manufacturer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-10-31 |
| Record revised | 2023-07-25 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization, Liquid Chemical |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 54240-00 | In distribution | |
| 54210-00 | In distribution | |
| 54230-00 | In distribution | |
| C8021-00 | Regular | In distribution |
| C8022-00 | Large | In distribution |
| 54000-03 | Regular | In distribution |
| C9809-00 | Juvenile | In distribution |
| 54150-00 | In distribution | |
| 54000-04 | Large | In distribution |
| 54000-02 | Juvenile | In distribution |
| C8020-00 | Juvenile | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| Novo Surgical Inc. | Novo Surgical, Inc. | 1 |
Showing 12 of 22. All products under Clamp, Penile
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.