Stradis Medical, LLC.
Dressing Change Tray with Chlorhexidine (Version or Model Number is CTDC-1000)
12manufacturers in China registered for this device type
116catalogue 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 | Stradis Healthcare, United States |
|---|---|
| FDA product code | MCY |
| Device type | Wound Dressing Kit |
| Device class | Class 2 |
| Regulation | 21 CFR 880.5075 |
| Record published | 2017-12-14 |
| Record revised | 2025-11-20 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Outer box of 30, outer box of 24, outer box of 20, outer box of 40, pack of 30, outer box of 25 |
| Distribution end date | 2023-02-09 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IM1241 | In distribution | |
| IM1246 | In distribution | |
| HCT5040CHG | In distribution | |
| IM1224A | In distribution | |
| HCT5040CHG1VG0 | In distribution | |
| HCT8275CP | In distribution | |
| HCT200GD-BP | In distribution | |
| HCT8275CP-B | In distribution | |
| CTDC1200C | In distribution | |
| DC-5070STKC | In distribution | |
| IM1222 | In distribution | |
| HCT6057CP-1 | In distribution | |
| DC-3050 | In distribution | |
| HCT8443CP-3 | In distribution | |
| IM1255 | In distribution | |
| IM1248 | In distribution | |
| HCT1313B | In distribution | |
| DC-5070C | In distribution | |
| IM1267 | In distribution | |
| 9009-1A | In distribution | |
| PMDC-2000C | In distribution | |
| IM1234 | In distribution | |
| HCT3058PX | In distribution | |
| IM1253 | In distribution | |
| RWM-69K-TA01 | In distribution | |
| RWM-DC57F | In distribution | |
| DC-610SN | In distribution | |
| IM1210 | In distribution | |
| DC-5070SN | In distribution | |
| HCT9555AI | In distribution | |
| HCT5040CHG-1 | In distribution | |
| ISDC-6180 | In distribution | |
| HCT100BP-1 | In distribution | |
| IM1256 | In distribution | |
| IM1231D | In distribution | |
| IM1216A | In distribution | |
| DC-560 | In distribution | |
| IM1219 | In distribution | |
| IM1231C | In distribution | |
| IM1250 | In distribution | |
| HCT9948BP-1 | In distribution | |
| IM1254 | In distribution | |
| IM1233 | In distribution | |
| DC8903CP-2 | In distribution | |
| IM1240A | In distribution | |
| DC-560A | In distribution | |
| IM1223 | In distribution | |
| MC-3513CL | In distribution | |
| IM1211 | In distribution | |
| HCT1212SB | In distribution | |
| DC352 | In distribution | |
| MMKDC-16831 | In distribution | |
| IM2002CLS | In distribution | |
| IM1249 | In distribution | |
| HCT9948BP1VG0 | In distribution | |
| IM2212 | In distribution | |
| TM18799 | Withdrawn | |
| DC8903CP | Withdrawn | |
| HCT8241BP-1 | Withdrawn | |
| DC-3073 | Withdrawn | |
| HCT8844BP | Withdrawn | |
| DC-1965C | Withdrawn | |
| RS-16456-1T | Withdrawn | |
| RWM-DLH14-NS | Withdrawn | |
| HCT222CK-2 | Withdrawn | |
| HCT8119CP-4 | Withdrawn | |
| DC-5150 | Withdrawn | |
| HCT541BP-2 | Withdrawn | |
| DCT-HIMA2012 | Withdrawn | |
| HCT2020CP | Withdrawn | |
| HCT9412CP-1 | Withdrawn | |
| DC355-S | Withdrawn | |
| TM6981 | Withdrawn | |
| HCT9450CP | Withdrawn | |
| DC-5080BP | Withdrawn | |
| RWM-DLH15C-NS | Withdrawn | |
| DC8292CP | Withdrawn | |
| RWM-DLH138-LS | Withdrawn | |
| IM1212 | Withdrawn | |
| DC-5073STKC | Withdrawn | |
| VA-101 | Withdrawn | |
| HCT200BP | Withdrawn | |
| IM1242 | Withdrawn | |
| DC350 | Withdrawn | |
| IM1245 | Withdrawn | |
| MC-3535PT | Withdrawn | |
| TM7296CP | Withdrawn | |
| HCT8136CP | Withdrawn | |
| IM1259 | Withdrawn | |
| IM1218 | Withdrawn | |
| IM1247 | Withdrawn | |
| DC-5080TC | Withdrawn | |
| HCT9948CPA | Withdrawn | |
| RXR-20451 | Withdrawn | |
| HCT8241BP | Withdrawn | |
| HCT8473-1 | Withdrawn | |
| DC-5070 | Withdrawn | |
| HCT8440TC | Withdrawn | |
| PMDC-2000C | Withdrawn | |
| DC350-CHG | Withdrawn | |
| IM1244 | Withdrawn | |
| CTDC1300C | Withdrawn | |
| CTDC-1001C | Withdrawn | |
| HCT8119CP-3 | Withdrawn | |
| IM1218-1 | Withdrawn | |
| TMDC1000 | Withdrawn | |
| TM1658 | Withdrawn | |
| HCT5052BP-1 | Withdrawn | |
| IM1217B | Withdrawn | |
| TMDCSA1 | Withdrawn | |
| TM7522CP | Withdrawn | |
| DC-5070STK | Withdrawn | |
| HCT8240CP | Withdrawn | |
| HCT9948BP | Withdrawn | |
| ACC-8180 | Withdrawn | |
| DC-5155 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medline Industries, Inc. | Medline Industries, Inc. | 1,221 |
| Medline | Medline Industries, Inc. | 184 |
| 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 |
| Curaplex | Bound Tree Medical, LLC | 8 |
| Cardinal Health | Cardinal Health 200, LLC | 5 |
Showing 12 of 25. All products under Wound Dressing Kit
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Stradis Healthcare | UDI-DI | 2022-12-15 | Class II | Process control | Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit. | 250 units |
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.