Aesculap
6 catalogue numbers from MG230, listed by Aesculap AG, Germany, under Clamp, Circumcision. 2 manufacturers in China are registered for this product code.
2manufacturers in China registered for this device type
6catalogue numbers in this listing
1recall
Who Else Makes It
Concentrated in Guangdong (1), Anhui (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Flexicare Medical (Dongguan) Ltd. | Dongguan | Guangdong | Contract manufacturer | 48 |
| Wuhu Snnda Medical Treatment Appliance Technology Co., Ltd. | Wuhu | Anhui | Manufacturer | 1 |
Record
| Listed by | Aesculap AG, Germany |
|---|---|
| FDA product code | HFX |
| Device type | Clamp, Circumcision |
| Device class | Class 2 |
| Regulation | 21 CFR 884.4530 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2016-09-23 |
| Record revised | 2020-01-15 (version 4) |
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 |
|---|---|---|
| MG230 | In distribution | |
| MG097R | In distribution | |
| MG228 | In distribution | |
| MG229 | In distribution | |
| MG096R | In distribution | |
| MG227 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| ShangRing | Wuhu Snnda Medical Treatment Appliance Technology Co., Ltd. | 24 |
| Centurion | Centurion Medical Products Corporation | 18 |
| Devon | Cardinal Health | 17 |
| Gomco Circumcision Clamp | Sontec Instruments, Inc. | 16 |
| Gomco | Allied Medical LLC | 9 |
| Circumplast | Emboss Medical Limited | 8 |
| Medical Action Industries | Medical Action Industries, Inc. | 4 |
| AccuCirc® | Clinical Innovations, LLC | 4 |
| Gomco Type Circumcision Clamp | Fine Surgical Instruments Inc. | 4 |
| Medline | Medline Industries, Inc. | 3 |
| Mogen Circumcision Clamp | Sontec Instruments, Inc. | 2 |
| Gomco Circumcision Clamp Chrome | Sontec Instruments, Inc. | 2 |
Showing 12 of 21. All products under Clamp, Circumcision
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 |
|---|---|---|---|---|---|
| 2016-10-28 | Class II | Under Investigation by firm | Aesculap has received complaints of excessive bleeding after use of Gomco Circumcision Clamps. | 437 units | 2018-01-30 |
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.