KerraLite Cool Border
Soothing, debriding and moisture-balancing dressing.
118manufacturers in China registered for this device type
3catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (33), Jiangsu (23), Guangdong (17). 16 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 |
| Allmed Medical Products Co., Ltd. | Zhijiang | Hubei | Contract manufacturer | 43 |
| Shanghai Care Us Medical Product Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 30 |
| Henso Medical (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 19 |
| Huizhou Foryou Medical Devices Co., Ltd. | Huizhou | Guangdong | Contract manufacturer | 18 |
| Wuhan Huawei Technology Co., Ltd. | Wuhan | Hubei | Contract manufacturer | 16 |
| Zhejiang Aoki Medical Dressing Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 16 |
| Hanghai Medical Products Co Ltd | Jinhua | Zhejiang | Contract manufacturer | 10 |
| Jiangsu Yizheng Carepro Medical Instruments Co., Ltd. | Yizheng | Jiangsu | Contract manufacturer | 8 |
| Winner Medical (Jiayu) Co., Ltd. | Jiayu | Hubei | Contract manufacturer | 7 |
| Smith & Nephew (Suzhou) Limited | Suzhou | Jiangsu | Contract manufacturer | 6 |
Showing 12 of 118. All 118 manufacturers in China registered for Dressing, Wound, Hydrogel Without Drug And/Or Biologic
Record
| Listed by | Crawford Healthcare Limited |
|---|---|
| FDA product code | NAE |
| Device type | Dressing, Wound, Hydrogel Without Drug And/Or Biologic |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4022 |
| Premarket notification | Exempt |
| Record published | 2019-10-01 |
| Record revised | 2020-09-09 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Keep dry; Special storage condition: Store out of direct sunlight; Storage environment temperature up to 77 °F |
| Packaging | Carton of 5, shipper of 550, shipper of 52, shipper of 32, shipper of 104 |
| Sizes | Length 3 to 6 in; height 3 to 6 in |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 4x4in | Length 4 in | In distribution |
| 6x6in | Length 6 in | In distribution |
| 3x3in | Height 3 in | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Spand-Gel | Medi-Tech, Inc. | 16 |
| BurnFree | Water-JEL Technologies, L.L.C. | 16 |
| Simpurity | Safe N Simple LLC | 15 |
| Lavior | Lavior Pharma Inc. | 9 |
| McKesson | Mckesson Medical-Surgical Inc. | 8 |
| Cutimed® | BSN Medical, Inc. | 8 |
| H&H | Tronjen Medical Technology Inc | 7 |
| 3M™ Kerralite Cool™ | 3M Deutschland GmbH | 7 |
| First Responder | Water-JEL Technologies, L.L.C. | 6 |
| Aquasite® | Derma Sciences Canada, Inc. | 5 |
| DermaSyn | Sion Brands LLC | 5 |
| Medline | Medline Industries, Inc. | 5 |
Showing 12 of 127. All products under Dressing, Wound, Hydrogel Without Drug And/Or Biologic
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.