3m™ Precise™
3M™ Precise™ Disposable Skin Staple Remover, Tweezer-Style SR-1
20manufacturers in China registered for this device type
11catalogue numbers in this listing
1510(k) clearance
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 | 3M Company, United States |
|---|---|
| FDA product code | GDT |
| Device type | Staple, Removable (Skin) |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4760 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-09-24 |
| Record revised | 2022-06-10 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Packaging | Box of 4, box of 3 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| SR-1 | 10 | In distribution | |
| 3996 | 6 | In distribution | |
| SR-3 | 10 | In distribution | |
| PGX-15W | 6 | In distribution | |
| DS-5 | 12 | In distribution | |
| DS-15 | 12 | In distribution | |
| PGX-35W | 6 | In distribution | |
| 3998 | 6 | In distribution | |
| 3997 | 6 | In distribution | |
| DS-25 | 12 | In distribution | |
| 3995 | 6 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| microMend PRO | Kitotech Medical Inc | 14 |
| Weck | Teleflex Medical LLC | 12 |
| 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)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K800535 | 1980-04-04 |
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.