Vein strippers are single use medical devices, sterilized by Ethylene Oxide, intended to be used for surgical stripping of varicose veins. This product is not intended to be used in the…
Vein strippers are single use medical devices, sterilized by Ethylene Oxide, intended to be used for surgical stripping of varicose veins. This product is not intended to be used in the central venous system. Model VE-022 model is intended for conventional stripping procedures.
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 Dormo-Strip | Listed by | Telic SAU |
| FDA product code | GAJ |
| Device type | Stripper, Vein, Disposable |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4800 |
| Premarket notification | Exempt |
| Record published | 2025-01-15 |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment humidity 20 to 80 % RH; Storage environment temperature 5 to 40 °C; Special storage condition: Keep dry; Special storage condition: Keep away from sunlight |
| Packaging | Service box of 12 |
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.