Kmedic
Freer Skin Hook 6" 2 Prong Sharp 2.5 Millimeter
19manufacturers in China registered for this device type
24catalogue numbers in this listing
4recalls on this code
Who Else Makes It
Concentrated in Jiangsu (7), Zhejiang (5), Shanghai (3). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| B.Braun Medical (Suzhou) Co,.Ltd | Suzhou | Jiangsu | Contract manufacturer | 37 |
| Malosa Medical Instruments (Changshu) Limited | Changshu | Jiangsu | Contract manufacturer | 24 |
| Yangzhou Haiwang Toothbrush Factory | Yangzhou | Jiangsu | Contract manufacturer | 12 |
| Chamfond Biotech Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 9 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Zimmer (Shanghai) Medical International Trading Co., Ltd. | Shanghai | Shanghai | Exporter | 106 |
| Zhejiang Yamei Medical Equipment Technology Co., Ltd. | Yang Jiao Lang Zin’An Town | Zhejiang | Manufacturer | 39 |
| Bothwin (Beijing) Medical Technology Co., Ltd. | Beijng | Beijing | Manufacturer | 25 |
| Tonglu Wanhe Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 24 |
| Jiangsu Hanheng Medical Technology Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 20 |
| Changsha Nice Medical Instrument Limited Company | Changsha | Hunan | Manufacturer | 17 |
Showing 12 of 19. All 19 manufacturers in China registered for Hook, Surgical, General & Plastic Surgery
Record
| Listed by | Teleflex Medical LLC, United States |
|---|---|
| FDA product code | GDG |
| Device type | Hook, Surgical, General & Plastic Surgery |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-09-15 |
| Record revised | 2026-02-06 (version 3) |
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, manufacturing date |
| Sizes | Length 12.1 to 17.8 cm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IPN014939 | Length 15.8 cm | In distribution |
| IPN014970 | Length 15.8 cm | In distribution |
| IPN014962 | Length 16.5 cm | In distribution |
| IPN014959 | Length 16.5 cm | In distribution |
| IPN015129 | Length 12.7 cm | In distribution |
| IPN014963 | Length 16.5 cm | In distribution |
| IPN014969 | Length 15.8 cm | In distribution |
| IPN014940 | Length 15.8 cm | In distribution |
| IPN015424 | Length 17.8 cm | In distribution |
| IPN014964 | Length 16.5 cm | In distribution |
| IPN014967 | Length 15.9 cm | In distribution |
| IPN014486 | Length 12.7 cm | In distribution |
| IPN014966 | Length 15.9 cm | In distribution |
| IPN014935 | Length 15.2 cm | In distribution |
| IPN014965 | Length 15.9 cm | In distribution |
| IPN014952 | Length 16.5 cm | In distribution |
| IPN014960 | Length 16.5 cm | In distribution |
| IPN014312 | Length 15.2 cm | In distribution |
| IPN014487 | Length 12.7 cm | In distribution |
| IPN014961 | Length 16.5 cm | In distribution |
| IPN014941 | Length 15.8 cm | In distribution |
| IPN014968 | Length 15.9 cm | In distribution |
| IPN015423 | Length 17.8 cm | In distribution |
| IPN014938 | Length 12.1 cm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Millennium | Avalign Technologies, Inc. | 202 |
| Ambler Surgical | Ambler Surgical, LLC | 192 |
| Aesculap | Aesculap AG | 178 |
| Surtex | Surtex Instruments Ltd | 138 |
| Sklar® | Sklar Corporation | 126 |
| Boss Instruments | Boss Instruments, Ltd. | 115 |
| Hayden Medical | Hayden Medical Inc | 100 |
| Integra® Jarit® | Integra LifeSciences Production Corporation | 97 |
| Life Instruments | Life Instrument Corp. | 97 |
| MSI Precision Specialty Instruments | MED Saver, Inc. | 95 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 83 |
| Novo Surgical Inc. | Novo Surgical, Inc. | 78 |
Showing 12 of 275. All products under Hook, Surgical, General & Plastic Surgery
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2011-12-06 | Not classified | Under Investigation by firm | Teleflex Medical received complaints that the elastic bands are breaking, cracking and /or deteriorating prior to their expiration date. If the elastic bands break during use there is a chance for operative exposure, loss of the band in the | to be obtained | 2014-05-20 |
| 2011-12-06 | Not classified | Under Investigation by firm | Teleflex Medical received complaints that the elastic bands are breaking, cracking and /or deteriorating prior to their expiration date. If the elastic bands break during use there is a chance for operative exposure, loss of the band in the | to be obtained | 2014-05-20 |
| 2008-05-12 | Not classified | Incorrect or no expiration date | The bands are breaking within the sealed packaging or in use prior to the expiration dates. | 5763 units | 2012-04-19 |
| 2008-05-12 | Not classified | Incorrect or no expiration date | The bands are breaking within the sealed packaging or in use prior to the expiration dates. | 8492 units | 2012-04-19 |
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.