TopClosure
13 catalogue numbers from 1S-M Military Kit 8mm, listed by I.V.T. Medical Ltd, under System, Skin Closure. 10 manufacturers in China are registered for this product code.
Who Else Makes It
Concentrated in Zhejiang (5), Shandong (2), Shanghai (1). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hubei V-Medical Products Co., Ltd. | Xiantao | Hubei | Contract manufacturer | 46 |
| Weihai Kangzheng Medical Equipments Technology Co., Ltd. | Weihai | Shandong | Contract manufacturer | 26 |
| Zhejiang Ailebao Medical Technology Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 11 |
| Ningbo Chinmed Technology Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 7 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Zhejiang Lidesen Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 100 |
| Anji Spenq Industrial Co., Ltd. | Huzhou | Zhejiang | Manufacturer | 85 |
| Shanghai Joy Crown Industry Co., Ltd. | Pu Dong New Area | Shanghai | Contract manufacturer | 64 |
| Nanjing J SUN Healthcare Co., Ltd. | Nanjing | Jiangsu | Repacker / relabeller | 56 |
| Ningbo Hysent Medical Technology Co., Ltd. | Ningbo | Zhejiang | Manufacturer | 13 |
Record
| Listed by | I.V.T. Medical Ltd |
|---|---|
| FDA product code | MKY |
| Device type | System, Skin Closure |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4320 |
| Premarket notification | Exempt |
| Record published | 2017-08-13 |
| Record revised | 2018-03-29 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Distribution carton of 10, blister box of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1S-M Military Kit 8mm | In distribution | |
| 1S-M Emergency Kit 8mm | In distribution | |
| 5S-VET Veterinary Pack 8mm | In distribution | |
| 1S-AD First-Aid Kit 4mm | In distribution | |
| 1S-M Rescue Kit 8mm | In distribution | |
| 3S Hospital Pack 8mm | In distribution | |
| 3S Hospital Pack 4mm | In distribution | |
| 1S Clinic Pack 4mm | In distribution | |
| 1S-VET Veterinary Pack 8mm | In distribution | |
| 1S-AD First-Aid Kit 8mm | In distribution | |
| 3S-M Rescue Kit 8mm | In distribution | |
| 3S Hospital Pack 6mm | In distribution | |
| 1S Clinic Pack 8mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Endure Industries | Endure Industries, Inc. | 9 |
| Dynamic Tissue Systems™ | Southmedic, Inc. | 8 |
| Dermaclose | Synovis Micro Companies Alliance | 6 |
| BandGrip® Micro-Anchor® Skin Closure | Bandgrip Inc. | 2 |
| Dialfix 18 | Dfix | 1 |
| Hemigard Interlock | Suturegard Medical, Inc. | 1 |
| Dialfix 11 | Dfix | 1 |
| Dialfix Plus 3 | Dfix | 1 |
| Dialfix 24 | Dfix | 1 |
| Suturegard® Interlock | Suturegard Medical, Inc. | 1 |
| Dialfix 15 | Dfix | 1 |
| Zip PreLoc 2 Wound Closure Device | Stryker GmbH | 1 |
Showing 12 of 16. All products under System, Skin Closure
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.