Weck
Snowden Pencer 35W Skin Stapler 6/BOX
20manufacturers in China registered for this device type
12catalogue numbers in this listing
3recalls on this code
Who Else Makes It
Concentrated in Zhejiang (7), Jiangsu (6), Guangdong (4). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Modern Medical Equipment Manufacturing Ltd. | Heng Li, Dongguan | Guangdong | Contract manufacturer | 26 |
| Ningbo Advan Electrical Co., Ltd. | Cixi | Zhejiang | Contract manufacturer | 5 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
| Huzhou Junda Industry Co., Ltd. | Anji | Zhejiang | Contract manufacturer | 129 |
| Zhejiang Mediunion Healthcare Group Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 105 |
| Zhejiang Lidesen Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 100 |
| Ningbo Greetmed Medical Instruments Co., Ltd. | Ningbo | Zhejiang | Specification developer | 75 |
| Orantech Inc. | Shenzhen | Guangdong | Contract manufacturer | 40 |
| Tiger Medical Group | Shanghai | Shanghai | Specification developer | 38 |
| Modern Medical Equipment Manufacturing (Qing Yuan) Ltd | Qing Yuan | Guangdong | Contract manufacturer | 26 |
| Shandong Haidike Medical Products Co., Ltd. | Heze | Shandong | Manufacturer | 22 |
Showing 12 of 20. All 20 manufacturers in China registered for Staple, Removable (Skin)
Record
| Listed by | Teleflex Medical LLC, United States |
|---|---|
| FDA product code | GDT |
| Device type | Staple, Removable (Skin) |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4760 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-09-15 |
| Record revised | 2026-02-09 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Box of 10, box of 6, box of 34, box of 12, case of 10, pack of 100 |
| Sizes | Length 5.6 to 6.5 in |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| IPN008700 | Length 5.6 in | In distribution | |
| IPN028494 | Length 6.5 in | 10 | In distribution |
| IPN008819 | Length 5.7 in | 35 | In distribution |
| IPN028493 | Length 5.7 in | 35 | In distribution |
| IPN008820 | Length 6.5 in | 10 | In distribution |
| IPN008853 | Length 6.5 in | 35 | In distribution |
| IPN925056 | Length 5.8 in | In distribution | |
| IPN914814 | Length 6.5 in | 10 | In distribution |
| IPN008820 | Length 6.5 in | 35 | In distribution |
| IPN028492 | Length 6.5 in | 35 | In distribution |
| IPN008818 | Length 6.5 in | 35 | In distribution |
| IPN028495 | Length 5.6 in | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| microMend PRO | Kitotech Medical Inc | 14 |
| 3M™ Precise™ | 3M Company | 11 |
| Proximate | Ethicon Endo-Surgery, Inc. | 6 |
| Michel Wound Clips | Sontec Instruments, Inc. | 5 |
| Medline Industries, Inc. | Medline Industries, Inc. | 5 |
| Multifire Premium | Covidien LP | 4 |
| Ethicon | Provision | 4 |
| Cardinal Health | Cardinal Health 200, LLC | 3 |
| microMend | Kitotech Medical Inc | 3 |
| BandGrip® Micro-Anchor® Skin Closure | Bandgrip Inc. | 2 |
| Arrow | Teleflex Medical LLC | 2 |
| SM | Covidien LP | 2 |
Showing 12 of 28. All products under Staple, Removable (Skin)
Recalls
3 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 |
|---|---|---|---|---|---|
| 2018-02-15 | Class II | Packaging process control | Some boxes are labeled as Visistat Wide devices, when in fact the contain Visistat Regular devices. The 6 individually packaged units within the boxes are correctly labeled. | 12 units | 2018-10-31 |
| 2017-03-24 | Class II | Error in labeling | Some boxes are labeled as containing Visistat Wide devices, when they in fact they contained Visistat Regular device. | 3594 eaches | |
| 2016-11-18 | Class II | Packaging process control | Sterility Deficiency: The packages are not sealed properly and thus the sterility is not assured. | 96,402 units (9,120 ea US, 87,282 ea OUS) | 2017-11-24 |
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.