NoseAlign
Cleft Nose Approximation Device Size # 3
2manufacturers in China registered for this device type
3catalogue 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 | Cleftalign Inc., United States |
|---|---|
| FDA product code | MZR |
| Device type | Topical Approximation System |
| Device class | Class 1 |
| Regulation | 21 CFR 880.5240 |
| Establishment | Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-11-24 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| NAS 03 | In distribution | |
| NAS 01 | In distribution | |
| NAS 02 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Clozex Wound Closure | Clozex Medical, Inc. | 15 |
| Leukostrip™ | Smith & Nephew, Inc. | 7 |
| 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.