DeRoyal
Large Moist Wound Pack 7C
12manufacturers in China registered for this device type
11catalogue 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 | Deroyal Industries, Inc., United States |
|---|---|
| FDA product code | MCY |
| Device type | Wound Dressing Kit |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5075 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-09-12 |
| Record revised | 2022-11-28 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Supplied as a kit | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Case of 10, case of 7, case of 50 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 47-WC004 | In distribution | |
| 47-WC003 | In distribution | |
| 47-803 | In distribution | |
| 47-758 | In distribution | |
| 47-WC002 | In distribution | |
| 47-WC005 | In distribution | |
| 47-805 | In distribution | |
| 47-WC001 | In distribution | |
| 47-702 | In distribution | |
| 47-WC006 | In distribution | |
| 47-802 | 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 |
| carePAC | Extremity Care | 11 |
| Medical Action Industries | Medical Action Industries, Inc. | 8 |
| Curaplex | Bound Tree Medical, LLC | 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.