Weck
WECK EFx Shield Port Site Closure System
8manufacturers in China registered for this device type
12catalogue numbers in this listing
2recalls on this 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 | 2020-05-12 |
| Record revised | 2020-12-04 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Packaging | Box of 5, case of 9, case of 8 |
| Sizes | Length 7.9 to 9.82 in |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IPN914219 | Length 9.82 in | In distribution |
| IPN914218 | Length 7.9 in | In distribution |
| IPN914220 | Length 9.82 in | In distribution |
| IPN011977 | Length 7.9 in | In distribution |
| IPN923663 | Length 7.9 in | In distribution |
| IPN011978 | Length 9.82 in | In distribution |
| IPN929372 | Length 7.9 in | In distribution |
| IPN922589 | Length 9.82 in | In distribution |
| IPN011979 | Length 9.82 in | In distribution |
| IPN922588 | Length 9.82 in | In distribution |
| EFX002 | Length 7.9 in | In distribution |
| IPN917216 | Length 7.9 in | 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 |
| Novo Surgical | Novo Surgical, Inc. | 11 |
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.