Key Surgical Suture Booties
Suture Booties, Asst, Sterile, 5 pair/pad; 5 pads/box (2y, 1r, 1w, 1b)
16manufacturers in China registered for this device type
8catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Jiangsu (8), Zhejiang (3), Shanghai (2). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Changzhou Health Microport Medical Device Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 10 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Zhejiang Biomet Medical Products Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 74 |
| Jiangsu JianYu Health Medical Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 35 |
| Suzhou Hengxiang IMP. & EXP. Co., Ltd. | Suzhou | Jiangsu | Exporter | 35 |
| Shanghai Wilpower Industrial Co., Ltd. | Shanghai | Shanghai | Exporter | 33 |
| Zhejiang Chuangxiang Medical Technology Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 27 |
| Suzhou Acmed Import & Export Co., Ltd. | Suzhou | Jiangsu | Exporter | 27 |
| Tonglu Wanhe Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Manufacturer | 24 |
| Asol Co., Ltd. | Huaian | Jiangsu | Manufacturer | 22 |
Showing 12 of 16. All 16 manufacturers in China registered for Clamp, Surgical, General & Plastic Surgery
Record
| Listed by | Key Surgical, LLC, United States |
|---|---|
| FDA product code | GDJ |
| Device type | Clamp, Surgical, General & Plastic Surgery |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-12-09 |
| Record revised | 2025-01-27 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Box of 5 |
| Sizes | Lumen/inner diameter 0.062 to 1 in |
| Distribution end date | 2025-04-24 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| VB-1115 | Lumen/Inner Diameter.062 in | In distribution |
| VB-1215 | Lumen/Inner Diameter.062 in | In distribution |
| VB-2000 | Lumen/Inner Diameter.062 in | In distribution |
| VB-1105 | Lumen/Inner Diameter 1 in | Withdrawn |
| VB-1110 | Lumen/Inner Diameter.062 in | Withdrawn |
| VB-1120 | Lumen/Inner Diameter.090 in | Withdrawn |
| VB-1315 | Lumen/Inner Diameter.062 in | Withdrawn |
| VB-1100 | Lumen/Inner Diameter.062 in | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| RZ Medizintechnik GmbH | RZ Medizintechnik Gmbh | 666 |
| Millennium | Avalign Technologies, Inc. | 131 |
| Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 127 |
| Aesculap | Aesculap AG | 92 |
| Sklar | Sklar Corporation | 79 |
| Hayden Medical | Hayden Medical Inc | 73 |
| Assi | Accurate Surgical & Scientific Instruments Corp. | 73 |
| Boss Instruments | Boss Instruments, Ltd. | 66 |
| Stille Hemostats | Stille AB | 66 |
| Novo Surgical | Novo Surgical, Inc. | 64 |
| Clamp, Surgical, General & Plastic Surgery | George Tiemann & Co. | 59 |
| Clamp | KLS-Martin L.P. | 59 |
Showing 12 of 208. All products under Clamp, Surgical, General & Plastic Surgery
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K895591 | 1989-10-20 |
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.