Stradis Healthcare
8 catalogue numbers from ZZ-0667, listed by Stradis Healthcare, United States, under Suture Removal Kit. 12 manufacturers in China are registered for this product code.
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 | Stradis Healthcare, United States |
|---|---|
| FDA product code | MCZ |
| Device type | Suture Removal Kit |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Premarket notification | Exempt |
| Record published | 2022-04-29 |
| Record revised | 2023-02-07 (version 3) |
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 25, pack of 25 |
| Distribution end date | 2023-02-06 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| ZZ-0667 | In distribution | |
| 698-026 | In distribution | |
| ZZ-0666 | In distribution | |
| 698-023 | Withdrawn | |
| ZZ-0665 | Withdrawn | |
| 698-024 | Withdrawn | |
| ZZ-0664 | Withdrawn | |
| 698-025 | Withdrawn |
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 |
| Centurion Medical Products Corp | Medline Industries, Inc. | 8 |
| MediChoice | Owens & Minor Distribution, Inc. | 8 |
Showing 12 of 35. All products under Suture Removal Kit
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2022-04-22 | Class II | Under Investigation by firm | There is uncertainty about the integrity of the methods used to ensure the sterile barrier integrity. | 7340 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.