Centurion
ST Skin Hook 1 Prong Blunt 6 1/2'(25762)
19manufacturers in China registered for this device type
8catalogue numbers in this listing
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 | Centurion Medical Products Corporation, United States |
|---|---|
| FDA product code | GDG |
| Device type | Hook, Surgical, General & Plastic Surgery |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Premarket notification | Exempt |
| Record published | 2022-01-01 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 20, case of 25 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| I68540 | In distribution | |
| 66660 | In distribution | |
| I68785 | In distribution | |
| 67810 | In distribution | |
| 67105 | In distribution | |
| I68660 | In distribution | |
| 67805 | In distribution | |
| I68655 | 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 Naming This Product
2 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Medline Industries, LP – Northfield | UDI-DI | 2024-11-12 | Class II | Process control | Weak seals may result in a breach of sterility, which may not be detectable to the user. This can lead to increased risk of contamination and infection. | 21,440 total |
| Medline Industries, LP – Northfield | UDI-DI | 2024-02-23 | Class II | Process control | Product may have a weak seal which may result in a breach of sterility of the contents if the seal fails. The weak seal may not be detectable by all users. | 1520 units |
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.