The Disposable Vein Hook is intended for single patient use for the treatment of superficial varicose veins and varicosities associated with superficial reflux and incompetence of the Great…
The Disposable Vein Hook is intended for single patient use for the treatment of superficial varicose veins and varicosities associated with superficial reflux and incompetence of the Great Saphenous Vein in the lower extremities.
Who Else Makes It
Concentrated in Jiangsu (2), Zhejiang (1). One is registered as a contract manufacturer, able to build to a specification.
Record
Regulatory record for Disposable Vein Hook | Listed by | Vascular Solutions LLC, United States |
| FDA product code | GAJ |
| Device type | Stripper, Vein, Disposable |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-09-05 |
| Record revised | 2022-02-22 (version 3) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Packaging | Box of 10 |
| Distribution end date | 2021-04-11 |
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.