Curaplex
BURN KIT COMPLETE, W/O WATER, incl Bag, Tape and Burn Mask/Towel/Sheet Dressings
12manufacturers in China registered for this device type
8catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (5), Hubei (2), Fujian (2).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Huzhou Junda Industry Co., Ltd. | Anji | Zhejiang | Contract manufacturer | 129 |
| Zhejiang Lidesen Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 100 |
| Anji Spenq Industrial Co., Ltd. | Huzhou | Zhejiang | Manufacturer | 85 |
| Hubei Qianjiang Kingphar Medical Material Co., Ltd. | Qianjiang | Hubei | Contract manufacturer | 52 |
| Jcmed Tianjin Import AND Export Co., Ltd. | Tianjin | Tianjin | Manufacturer | 51 |
| Anji Hongde Medical Products Co., Ltd. | Huzhou | Zhejiang | Contract manufacturer | 47 |
| Bestreat Safety & First AID Solution Co., Ltd. | Wuhan | Hubei | Manufacturer | 35 |
| Xiamen Ortocare Sports Health Co., Ltd. | Xiamen Free Trade Zone | Fujian | Contract manufacturer | 32 |
| Taizhou Rich Medical Products Co., Ltd. | Taizhou | Jiangsu | Contract manufacturer | 20 |
| Anji Fang Yuan Sanitary Material Co., Ltd. | Anji | Zhejiang | Repacker / relabeller | 13 |
| Shandong Succare Medical Co., Ltd. | Zibo | Shandong | Manufacturer | 12 |
| Ayida (Xiamen) P&C Technology Co., Ltd. | Xiamen | Fujian | Manufacturer | 8 |
Record
| Listed by | Bound Tree Medical, LLC, United States |
|---|---|
| FDA product code | MCY |
| Device type | Wound Dressing Kit |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5075 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-12-14 |
| Record revised | 2019-09-10 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 670134-KIT | In distribution | |
| 683924OD | In distribution | |
| 1510-77719 | In distribution | |
| 683921OD | In distribution | |
| 683925OD | In distribution | |
| 1777-S | In distribution | |
| 8600-01093 | In distribution | |
| 8600-01249 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medline Industries, Inc. | Medline Industries, Inc. | 1,221 |
| Medline | Medline Industries, Inc. | 184 |
| Stradis Medical, LLC. | Stradis Healthcare | 116 |
| Busse Hospital Disposables | Robert Busse & Co., Inc. | 24 |
| Centurion | Centurion Medical Products Corporation | 24 |
| Centurion Medical Products Corp | Medline Industries, Inc. | 15 |
| Wound CareKit | Mirodx, LLC | 12 |
| LSL Healthcare | Lsl Industries, Inc. | 12 |
| DeRoyal | Deroyal Industries, Inc. | 11 |
| carePAC | Extremity Care | 11 |
| Medical Action Industries | Medical Action Industries, Inc. | 8 |
| Cardinal Health | Cardinal Health 200, LLC | 5 |
Showing 12 of 25. All products under Wound Dressing Kit
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.