Devon
17 catalogue numbers from 52000031, listed by Cardinal Health, United States, under Clamp, Circumcision. 2 manufacturers in China are registered for this product code.
2manufacturers in China registered for this device type
17catalogue numbers in this listing
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 | Cardinal Health, United States |
|---|---|
| FDA product code | HFX |
| Device type | Clamp, Circumcision |
| Device class | Class 2 |
| Regulation | 21 CFR 884.4530 |
| Establishment | Contract manufacturer, Reprocessor, Contract steriliser, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K040052 |
| Record published | 2016-09-24 |
| Record revised | 2019-07-01 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: ; |
| Packaging | Case of 20, carton of 10, case of 30 |
| Sizes | Outer diameter 1.1 to 1.45 cm |
| Distribution end date | 2019-07-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 52000031 | Outer Diameter 1.1 cm | In distribution |
| 52000037 | In distribution | |
| 52000030 | In distribution | |
| 52000055 | In distribution | |
| 52000081 | Outer Diameter 1.1 cm | In distribution |
| 52000058 | Outer Diameter 1.1 cm | In distribution |
| 52000059 | Outer Diameter 1.3 cm | In distribution |
| 52000083 | Outer Diameter 1.3 cm | In distribution |
| 52000033 | Outer Diameter 1.3 cm | In distribution |
| 52000085 | In distribution | |
| 52000006 | Withdrawn | |
| 56421 | Withdrawn | |
| 56423 | Outer Diameter 1.3 cm | Withdrawn |
| 52000040 | Withdrawn | |
| 52000034 | Withdrawn | |
| 52000005 | Withdrawn | |
| 56242 | Outer Diameter 1.45 cm | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| ShangRing | Wuhu Snnda Medical Treatment Appliance Technology Co., Ltd. | 24 |
| Centurion | Centurion Medical Products Corporation | 18 |
| Gomco Circumcision Clamp | Sontec Instruments, Inc. | 16 |
| Gomco | Allied Medical LLC | 9 |
| Circumplast | Emboss Medical Limited | 8 |
| Aesculap | Aesculap AG | 6 |
| 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
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.