Novaplus®
Kit: Laceration NOVAPLUS 20/Cs
2manufacturers in China registered for this device type
20catalogue 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 | Medical Action Industries, Inc., United States |
|---|---|
| FDA product code | OVN |
| Device type | Suture Kit |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4830 |
| Premarket notification | Exempt |
| Record published | 2018-08-15 |
| Record revised | 2019-03-08 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Over the counter | Yes |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: STORE AT ROOM TEMPERATURE |
| Packaging | Pack of 20 |
| Distribution end date | 2022-11-23 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 56607 | In distribution | |
| 56723 | In distribution | |
| 56717 | In distribution | |
| 78808 | Withdrawn | |
| 58910 | Withdrawn | |
| 58909 | Withdrawn | |
| 56654 | Withdrawn | |
| 78810 | Withdrawn | |
| 56656 | Withdrawn | |
| 58913 | Withdrawn | |
| 56650 | Withdrawn | |
| 56679 | Withdrawn | |
| 56626 | Withdrawn | |
| 56671 | Withdrawn | |
| 56633 | Withdrawn | |
| 78811 | Withdrawn | |
| 58914 | Withdrawn | |
| 56719 | Withdrawn | |
| 56711 | Withdrawn | |
| 56726 | Withdrawn |
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 |
| Medline Industries, Inc. | Medline Industries, Inc. | 8 |
| DeRoyal | Deroyal Industries, Inc. | 7 |
| 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.