Duns Number:080914995
Catalog Number
-
Brand Name
Vein Distention
Version/Model Number
400
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)
Yes
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
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
DWP
Product Code Name
DILATOR, VESSEL, SURGICAL
Public Device Record Key
6370e32e-ae69-44bb-bde9-b9fbe72777fa
Public Version Date
August 15, 2018
Public Version Number
3
DI Record Publish Date
August 09, 2016
Package DI Number
10803622133135
Quantity per Package
5
Contains DI Package
00803622133138
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 44 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 479 |
| 3 | A medical device with high risk that requires premarket approval | 30 |