FixPad Anchoring Device
Catalogue number 1800-0005, listed by Fortune Medical Instrument Corp., Taiwan, under Topical Approximation System. 2 manufacturers in China are registered for this product code.
2manufacturers in China registered for this device type
1catalogue number
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 | Fortune Medical Instrument Corp., Taiwan |
|---|---|
| FDA product code | MZR |
| Device type | Topical Approximation System |
| Device class | Class 1 |
| Regulation | 21 CFR 880.5240 |
| Establishment | Contract manufacturer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2021-11-15 |
| Record revised | 2026-05-18 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 1800-0005 | 30 | 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 |
| LipAlign | Cleftalign Inc. | 3 |
| Dynamic Tissue Systems™ | Southmedic, Inc. | 2 |
| Leukostrip 6.4X102MM CTN 50 | Smith & Nephew, Inc. | 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.