Duns Number:832696038
Device Description: MAYO EXTERNAL VEIN STRIPPER ANGLED SHAFT INTERNAL RING SIZE 3/8"(10MM) OVERALL LENGTH 15"( MAYO EXTERNAL VEIN STRIPPER ANGLED SHAFT INTERNAL RING SIZE 3/8"(10MM) OVERALL LENGTH 15"(38.1CM)
Catalog Number
SU11850037
Brand Name
V. Mueller
Version/Model Number
SU11850037
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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)
Yes
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
18449d16-2e37-474e-992a-4ac233dbe4b7
Public Version Date
March 06, 2019
Public Version Number
2
DI Record Publish Date
September 17, 2018
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 | 8016 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 6223 |