Duns Number:120818216
Device Description: 5.5F X 10CM PTFE TEARAWAY INTRODUCER
Catalog Number
VAT5510
Brand Name
VYGON
Version/Model Number
VAT5510
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
Yes
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
DYB
Product Code Name
INTRODUCER, CATHETER
Public Device Record Key
f88882a5-668b-47ee-973c-d56d034ab8c9
Public Version Date
October 06, 2020
Public Version Number
2
DI Record Publish Date
March 25, 2020
Package DI Number
30849884004244
Quantity per Package
20
Contains DI Package
00849884004243
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 124 |
2 | A medical device with a moderate to high risk that requires special controls. | 833 |