Avalign
Umbilical Scissor
9manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Jiangsu (4), Shanghai (2), Shandong (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jiangsu JianYu Health Medical Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 35 |
| Jiangsu Huadong Medical Device Industry Co., Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 29 |
| Jingmen Huasheng Asia Dynamics Sanitary Products Co., Ltd. | Jingmen | Hubei | Contract manufacturer | 23 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Ningbo Ningyuan Import & Export Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 80 |
| Suzhou Pipi Medical Products Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 48 |
| Shanghai Wilpower Industrial Co., Ltd. | Shanghai | Shanghai | Exporter | 33 |
| Suzhou Acmed Import & Export Co., Ltd. | Suzhou | Jiangsu | Exporter | 27 |
Record
| Listed by | Avalign Technologies, Inc., United States |
|---|---|
| FDA product code | HDJ |
| Device type | Scissors, Umbilical |
| Device class | Class 1 |
| Regulation | 21 CFR 884.4520 |
| Establishment | Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-06-23 |
| Record revised | 2023-07-06 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| VM56-6286 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medicon | Medicon eG. Chirurgiemechaniker-Genossenschaft | 5 |
| Benco | Benco Dental Supply Co. | 4 |
| Gimmi | Gimmi Gmbh | 4 |
| Aesculap | Aesculap AG | 4 |
| Ambler Surgical | Ambler Surgical, LLC | 2 |
| Novo Surgical | Novo Surgical, Inc. | 2 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 2 |
| Symmetry Busch | Aspen Surgical Products, Inc. | 2 |
| Novo Surgical Inc. | Novo Surgical, Inc. | 2 |
| gSource | Gsource, LLC. | 1 |
| Quinelato | Schobell Industrial Ltda | 1 |
| Medichoice | Owens & Minor Distribution, Inc. | 1 |
Showing 12 of 22. All products under Scissors, Umbilical
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.