Duns Number:257382580
Device Description: Surgical instruments for varicose extraction (200 & 300 mm)
Catalog Number
-
Brand Name
Dubois Twistripper (set)
Version/Model Number
A1-350
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 24, 2022
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GAI
Product Code Name
Stripper, Vein, Reusable
Public Device Record Key
5d584fb4-3e86-4345-aa21-818bc5d9aaff
Public Version Date
March 25, 2022
Public Version Number
2
DI Record Publish Date
November 28, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 192 |
2 | A medical device with a moderate to high risk that requires special controls. | 88 |