Silon-LTS 9×12
Low Temperature Splinting
85manufacturers in China registered for this device type
1catalogue number
7510(k) clearances naming this product code
Who Else Makes It
Concentrated in Zhejiang (23), Jiangsu (14), Shanghai (13). 14 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Rollmed Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 127 |
| Hubei V-Medical Products Co., Ltd. | Xiantao | Hubei | Contract manufacturer | 46 |
| Shanghai Care Us Medical Product Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 30 |
| Yiwu Haoding Medical Co., Ltd. | Yiwu | Zhejiang | Contract manufacturer | 23 |
| Changzhou Recoo Healthcare Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 19 |
| Henso Medical (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 19 |
| Huizhou Foryou Medical Devices Co., Ltd. | Huizhou | Guangdong | Contract manufacturer | 18 |
| Henan Huibo Medical Co., Ltd. | Nanyang | Henan | Contract manufacturer | 17 |
| Zhende Medical Co., Ltd. | Shaoxing | Zhejiang | Contract manufacturer | 14 |
| Shanghai Chuangshi Medical Technology (Group) Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 14 |
| Winner Medical (Huanggang) Co., Ltd. | Huanggang | Hubei | Contract manufacturer | 9 |
| Smith & Nephew (Suzhou) Limited | Suzhou | Jiangsu | Contract manufacturer | 6 |
Showing 12 of 85. All 85 manufacturers in China registered for Elastomer, Silicone, For Scar Management
Record
| Listed by | BIO MED Sciences, Inc., United States |
|---|---|
| FDA product code | MDA |
| Device type | Elastomer, Silicone, For Scar Management |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4025 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K945892 |
| Record published | 2023-12-31 |
| Record revised | 2024-02-16 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, expiry date |
| Packaging | Box of 10 |
| Sizes | Width 9 in; width 23 cm; length 12 in; length 30 cm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 4608 | Width 9 in | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| EPI-Derm | Biodermis LLC | 77 |
| Scar AID | Biodermis LLC | 57 |
| NewGel+ Silicone Gel Sheeting | Newmedical Technology, Inc. | 28 |
| Silagen Silicone Gel Sheeting | Newmedical Technology, Inc. | 24 |
| Dermasof | Biodermis LLC | 20 |
| ScarMD | AIM Medical Inc | 14 |
| Scar Fx | Scar Heal | 14 |
| Cimeosil® Scar Management, Gel Sheet | Implantech Associates, Inc. | 13 |
| Therafoam | Biodermis LLC | 10 |
| Gelzone Wrap | Implantech Associates, Inc. | 10 |
| NEW Beginnings® Gelshapes® | PMT Corp. | 9 |
| Invisiderm™ Scar Management, Gel Sheet | Implantech Associates, Inc. | 8 |
Showing 12 of 137. All products under Elastomer, Silicone, For Scar Management
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K023136 | 2002-10-16 |
| K002109 | 2000-08-31 |
| K982036 | 1998-08-06 |
| K952546 | 1995-08-07 |
| K946362 | 1995-07-13 |
| K945892 | 1995-03-03 |
| K932214 | 1994-01-06 |
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.