Sklar®
Censitrac Ready Freer Skin HK 2PR SHP 2.5MM 6 IN
19manufacturers in China registered for this device type
126catalogue numbers in this listing
1recall
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 | Sklar Corporation, 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, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-12-03 |
| Record revised | 2022-09-23 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, serial number |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 47-2558 | In distribution | ||
| 98-7322 | In distribution | ||
| 47-2548 | In distribution | ||
| 47-2651 | In distribution | ||
| 40-8364 | In distribution | ||
| 47-2542 | In distribution | ||
| 47-2589 | In distribution | ||
| 21-825 | 12 | In distribution | |
| 50-1912 | In distribution | ||
| 93-8006 | In distribution | ||
| 47-2583 | In distribution | ||
| 40-6856 | In distribution | ||
| 50-1307 | In distribution | ||
| 47-2552 | In distribution | ||
| 47-2299 | In distribution | ||
| 50-1308 | In distribution | ||
| 50-1790C | In distribution | ||
| 47-2550 | In distribution | ||
| 47-2555 | In distribution | ||
| 47-2570 | In distribution | ||
| 47-2670 | In distribution | ||
| 47-2572C | In distribution | ||
| 45-6235 | In distribution | ||
| 47-2510 | In distribution | ||
| 96-2229 | 25 | In distribution | |
| 47-2505C | In distribution | ||
| 47-2656 | In distribution | ||
| 49-2265 | In distribution | ||
| 98-801 | In distribution | ||
| 45-6236 | In distribution | ||
| 47-2462C | In distribution | ||
| 45-6237 | In distribution | ||
| 47-3540 | In distribution | ||
| 47-2502C | In distribution | ||
| 47-2507 | In distribution | ||
| 47-2575 | In distribution | ||
| 41-1281 | In distribution | ||
| 50-1314 | In distribution | ||
| 47-2680 | In distribution | ||
| 50-1585 | In distribution | ||
| 96-2231M | 25 | In distribution | |
| 47-2660 | In distribution | ||
| 96-2223M | 25 | In distribution | |
| 41-1283 | In distribution | ||
| 21-392 | 12 | In distribution | |
| 97-398 | In distribution | ||
| 47-2502 | In distribution | ||
| 47-2570C | In distribution | ||
| 47-2556 | In distribution | ||
| 97-394 | In distribution | ||
| 47-2584 | In distribution | ||
| 47-2581 | In distribution | ||
| 47-2586 | In distribution | ||
| 47-2312 | In distribution | ||
| 96-2225 | 25 | In distribution | |
| 47-2551 | In distribution | ||
| 41-1279 | In distribution | ||
| 98-7323 | In distribution | ||
| 98-821 | In distribution | ||
| 47-2758 | In distribution | ||
| 47-2588 | In distribution | ||
| 98-7321 | In distribution | ||
| 47-2554 | In distribution | ||
| 97-390 | In distribution | ||
| 60-6280 | In distribution | ||
| 97-0543 | In distribution | ||
| 47-2530 | In distribution | ||
| 47-2587 | In distribution | ||
| 47-2760 | In distribution | ||
| 47-2061 | In distribution | ||
| 40-6857C | In distribution | ||
| 50-1309 | In distribution | ||
| 50-1792 | In distribution | ||
| 47-2507C | In distribution | ||
| 60-5810 | In distribution | ||
| 06-4175 | In distribution | ||
| 47-2500C | In distribution | ||
| 40-6858C | In distribution | ||
| 60-5820 | In distribution | ||
| 47-2500 | In distribution | ||
| 50-1310 | In distribution | ||
| 50-1790 | In distribution | ||
| 47-2760C | In distribution | ||
| 47-2580 | In distribution | ||
| 95-801 | In distribution | ||
| 96-2485 | 25 | In distribution | |
| 96-2225M | 25 | In distribution | |
| 40-6855 | In distribution | ||
| 47-2555C | In distribution | ||
| 96-2229M | 25 | In distribution | |
| 96-2485M | 25 | In distribution | |
| 47-2512 | In distribution | ||
| 47-2650 | In distribution | ||
| 47-2505 | In distribution | ||
| 06-4172 | In distribution | ||
| 21-394 | 12 | In distribution | |
| 21-821 | 12 | In distribution | |
| 98-521 | In distribution | ||
| 47-2300 | In distribution | ||
| 47-2510C | In distribution | ||
| 96-2227M | 25 | In distribution | |
| 40-6858 | In distribution | ||
| 41-1282 | In distribution | ||
| 47-2557 | In distribution | ||
| 50-1685 | In distribution | ||
| 40-6857 | In distribution | ||
| 41-1278 | In distribution | ||
| 95-821 | In distribution | ||
| 97-392 | In distribution | ||
| 40-7614 | In distribution | ||
| 47-2302 | In distribution | ||
| 97-391 | In distribution | ||
| 96-2223 | 25 | In distribution | |
| 47-2330 | In distribution | ||
| 93-479 | In distribution | ||
| 96-2227 | 25 | In distribution | |
| 47-2553 | In distribution | ||
| 21-390 | 12 | In distribution | |
| 47-2651C | In distribution | ||
| 47-2646 | In distribution | ||
| 21-801 | 12 | In distribution | |
| 47-2582 | In distribution | ||
| 47-2462 | In distribution | ||
| 40-7613 | In distribution | ||
| 93-8007 | In distribution | ||
| 47-2572 | 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 |
| 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 |
| Gen2 | Surgix Medical LLC | 76 |
Showing 12 of 275. All products under Hook, Surgical, General & Plastic Surgery
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 |
|---|---|---|---|---|
| 2024-12-03 | Class II | Under Investigation by firm | Reports of various packaging issues that may result in a breach of the sterile barrier. | 1050 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.