Leukostrip™
Leukostrip S. Wound closure strips. 6.4mm x 76mm Carton of 50
2manufacturers in China registered for this device type
7catalogue numbers in this listing
Who Else Makes It
All of them in Shanghai. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai ISO Medical Products Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 8 |
| Shanghai NEO-Medical Import & Export Co., Ltd. | Shanghai | Shanghai | Exporter | 59 |
Record
| Listed by | Smith & Nephew, Inc., United States |
|---|---|
| FDA product code | MZR |
| Device type | Topical Approximation System |
| Device class | Class 1 |
| Regulation | 21 CFR 880.5240 |
| Establishment | Contract manufacturer, Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2021-11-19 |
| Record revised | 2023-09-07 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
| Packaging | Carton of 10, case of 20, case of 4, carton of 50, carton of 25 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 66002883 | In distribution | |
| 66002881 | In distribution | |
| 66002882 | In distribution | |
| 66072955 | In distribution | |
| 66002953 | In distribution | |
| 66072954 | In distribution | |
| 66002952 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Clozex Wound Closure | Clozex Medical, Inc. | 15 |
| NoseAlign | Cleftalign Inc. | 3 |
| LipAlign | Cleftalign Inc. | 3 |
| Dynamic Tissue Systems™ | Southmedic, Inc. | 2 |
| Leukostrip 6.4X102MM CTN 50 | Smith & Nephew, Inc. | 1 |
| FixPad Anchoring Device | Fortune Medical Instrument Corp. | 1 |
| Leukostrip 4X38MM CTN 50 | Smith & Nephew, Inc. | 1 |
| Leukostrip 6.4X76MM CTN 50 | Smith & Nephew, Inc. | 1 |
| Leukostrip 13X102MM CTN 50 | Smith & Nephew, Inc. | 1 |
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.