Aspen® Flexible Light Handle Adapter
Intent to be used with Aspen Surgical Disposable light Handle covers.
3manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
All of them in Jiangsu. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Changzhou Jiuhong Medical Instrument Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 10 |
| Jiangsu Vedkang Medical Science and Technology Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 20 |
| Changzhou Intl. Trade & Enterprises Cooperative Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 14 |
Record
| Listed by | Aspen Surgical Products, Inc., United States |
|---|---|
| FDA product code | FAT |
| Device type | Bougie, Esophageal, And Gastrointestinal, Gastro-Urology |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5365 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Record published | 2016-09-17 |
| Record revised | 2021-03-04 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| LT-9534X | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Pilling | Teleflex Medical LLC | 128 |
| WeightRight® | Diversatek Healthcare Inc | 50 |
| M-Flex® | Diversatek Healthcare Inc | 46 |
| Aspen® Flexible Light Handle Cover | Aspen Surgical Products, Inc. | 3 |
| Endolumik | Endolumik | 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.