DeRoyal
Stainless Suture Removal Set
12manufacturers in China registered for this device type
3catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (6), Zhejiang (2), Hubei (2). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Conod Medical Co., Limited | Changshu | Jiangsu | Contract manufacturer | 48 |
| Allmed Medical Products Co., Ltd. | Zhijiang | Hubei | Contract manufacturer | 43 |
| Primecare Medical (Suzhou) Co., Ltd. | Changshu | Jiangsu | Contract manufacturer | 20 |
| Derma Sciences Nantong Incorporation | Development | Jiangsu | Contract manufacturer | 19 |
| Jiangsu Classic NEW-Type Medical Products Co., Ltd. | Yancheng | Jiangsu | Contract manufacturer | 13 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| Zhejiang Lidesen Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 100 |
| Amsino Medical (Kunshan) Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 53 |
| Allmed Industrial Limited | Shenzhen | Guangdong | Manufacturer | 42 |
| Hubei Lanbin Medical Group Co., Ltd. | Xiaogan | Hubei | Contract manufacturer | 33 |
| Hangzhou Primecare Medical Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 29 |
| Excellent Medical Technology Co., Ltd. | Hong Kong | Hong Kong | Specification developer | 17 |
Record
| Listed by | Deroyal Industries, Inc., United States |
|---|---|
| FDA product code | MCZ |
| Device type | Suture Removal Kit |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2017-04-18 |
| Record revised | 2018-03-29 (version 2) |
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 | Case of 50 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 47-513 | In distribution | |
| 32-1695 | In distribution | |
| 32-351 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cardinal Health | Cardinal Health 200, LLC | 166 |
| Medical Action Industries | Medical Action Industries, Inc. | 99 |
| Centurion | Centurion Medical Products Corporation | 71 |
| Medline Industries, Inc. | Medline Industries, Inc. | 48 |
| LSL Healthcare | Lsl Industries, Inc. | 42 |
| Medline | Medline Industries, Inc. | 42 |
| E.M Adams Co., Inc. | E.M. Adams Co., Inc. | 33 |
| Novaplus® | Medical Action Industries, Inc. | 16 |
| McKesson | Mckesson Medical-Surgical Inc. | 11 |
| Trinity Sterile, Inc. | Trinity Sterile, Inc. | 10 |
| Stradis Healthcare | Stradis Healthcare | 8 |
| Centurion Medical Products Corp | Medline Industries, Inc. | 8 |
Showing 12 of 35. All products under Suture Removal 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.