Pilling
10 catalogue numbers from IPN006778, listed by Teleflex Medical LLC, United States, under Instrument, Ligature Passing And Knot Tying. 8 manufacturers in China are registered for this product code.
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 | Teleflex Medical LLC, 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, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-09-15 |
| Record revised | 2026-02-06 (version 4) |
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 8.6 to 18.1 cm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IPN006778 | Length 10.1 cm | In distribution |
| IPN006777 | Length 10.1 cm | In distribution |
| IPN006183 | Length 18 cm | In distribution |
| IPN006780 | Length 8.6 cm | In distribution |
| IPN006553 | Length 18.1 cm | In distribution |
| IPN006182 | Length 12 cm | In distribution |
| IPN006779 | Length 8.6 cm | In distribution |
| IPN006552 | Length 18.1 cm | In distribution |
| IPN006180 | Length 12 cm | In distribution |
| IPN006179 | Length 12 cm | In distribution |
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 |
| Wexler Surgical, Inc. | Wexler Surgical, Inc. | 20 |
| Gimmi | Gimmi Gmbh | 16 |
| Marina Medical | Marina Medical Instruments, Inc. | 16 |
| Weck | Teleflex Medical LLC | 12 |
Showing 12 of 156. All products under Instrument, Ligature Passing And Knot Tying
Recalls
2 of these are 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 | Closed |
|---|---|---|---|---|---|
| 2016-11-16 | Class II | Other | The devices wings may become partially detached from the EFx Shield during use. | 2265 units | 2017-12-13 |
| 2016-03-24 | Class II | Unknown/Undetermined by firm | Incorrect expiration date was printed on the product label. | 45 | 2020-09-25 |
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.