Arrow
2 Staple Anchoring Devices
20manufacturers in China registered for this device type
2catalogue 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 | 2022-11-29 |
| Record revised | 2026-05-18 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Box of 25, case of 2 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IPN920006 | In distribution | |
| IPN035928 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| microMend PRO | Kitotech Medical Inc | 14 |
| Weck | Teleflex Medical LLC | 12 |
| 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 |
| 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.