LipAlign
Cleft Lip Approximation Tape Size Medium
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 | 2024-08-20 |
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 |
|---|---|---|
| LAT-M | In distribution | |
| LAT-L | In distribution | |
| LAT-S | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Clozex Wound Closure | Clozex Medical, Inc. | 15 |
| Leukostrip™ | Smith & Nephew, Inc. | 7 |
| NoseAlign | 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.