DeRoyal
Adult/Peds Suture Laceration Tray
2manufacturers in China registered for this device type
7catalogue numbers in this listing
Who Else Makes It
Concentrated in Hubei (1), Zhejiang (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hubei Lanbin Medical Group Co., Ltd. | Xiaogan | Hubei | Contract manufacturer | 33 |
| Ningbo Greatcare Medical Instruments Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 10 |
Record
| Listed by | Deroyal Industries, Inc., United States |
|---|---|
| FDA product code | OVN |
| Device type | Suture Kit |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4830 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-12-29 |
| Record revised | 2018-03-29 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 50, case of 20, case of 30 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 47-511 | In distribution | |
| 47-514 | In distribution | |
| 47-516 | In distribution | |
| 89-8485 | In distribution | |
| 50-502 | In distribution | |
| 89-6249 | In distribution | |
| 50-501 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Deknatel | Teleflex Medical LLC | 360 |
| Medical Action Industries | Medical Action Industries, Inc. | 326 |
| Syneture | Covidien LP | 321 |
| Cardinal Health | Cardinal Health 200, LLC | 220 |
| LSL Healthcare | Lsl Industries, Inc. | 41 |
| Medichoice | Owens & Minor Distribution, Inc. | 22 |
| Novaplus® | Medical Action Industries, Inc. | 20 |
| Medline Industries, Inc. | Medline Industries, Inc. | 8 |
| Vygon | Vygon Corp. | 6 |
| ACS | American Contract Systems, Inc. | 5 |
| McKesson | Mckesson Medical-Surgical Inc. | 3 |
| Regard™ | Resource Optimization & Innovation, L.L.C. | 2 |
Showing 12 of 28. All products under Suture 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.