Wexler Surgical, Inc.
20 catalogue numbers from DL0003-B, listed by Wexler Surgical, Inc., United States, under Instrument, Ligature Passing And Knot Tying. 8 manufacturers in China are registered for this product code.
8manufacturers in China registered for this device type
20catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (4), Shanghai (1), Shandong (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Beilun Plastech Inc | Ningbo | Zhejiang | Contract manufacturer | 13 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Huzhou Junda Industry Co., Ltd. | Anji | Zhejiang | Contract manufacturer | 129 |
| Hangzhou Kangji Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 27 |
| Hangzhou Endo Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 19 |
| Changzhou 3R Medical Device Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 16 |
| Auckland Medical Technology (Sichuan) Co., Ltd. | Luzhou | Sichuan | Manufacturer | 3 |
Record
| Listed by | Wexler Surgical, Inc., United States |
|---|---|
| FDA product code | HCF |
| Device type | Instrument, Ligature Passing And Knot Tying |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-02-26 |
| Record revised | 2022-11-28 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
| Distribution end date | 2022-09-06 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DL0003-B | In distribution | |
| DL0100-R | In distribution | |
| DL0106-W | In distribution | |
| DL0101-B | In distribution | |
| DL0100-B | In distribution | |
| DL0200-B | In distribution | |
| DL0100-W | In distribution | |
| DL0200-R | In distribution | |
| DL0202-P | In distribution | |
| DL0200-Y | In distribution | |
| DL0002-W | In distribution | |
| DL0100-Y | In distribution | |
| DL0101-R | In distribution | |
| DL0101-W | In distribution | |
| DL0001-R | In distribution | |
| DL0200-W | In distribution | |
| DL0105-W | In distribution | |
| DL0101-Y | In distribution | |
| DL0013-B | Withdrawn | |
| DL0201-Y | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Boss Instruments | Boss Instruments, Ltd. | 360 |
| Elmed | Elmed, Inc. | 99 |
| MSI Precision Specialty Instruments | MED Saver, Inc. | 69 |
| Millennium | Avalign Technologies, Inc. | 53 |
| Castroviejo Needle Holder | Sontec Instruments, Inc. | 46 |
| Elmed Incorporated | Elmed, Inc. | 38 |
| Aesculap | Aesculap AG | 26 |
| Barraquer Needle Holder | Sontec Instruments, Inc. | 23 |
| Gimmi | Gimmi Gmbh | 16 |
| Marina Medical | Marina Medical Instruments, Inc. | 16 |
| Weck | Teleflex Medical LLC | 12 |
| Novo Surgical | Novo Surgical, Inc. | 11 |
Showing 12 of 156. All products under Instrument, Ligature Passing And Knot Tying
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.