Duns Number:392994778
Device Description: Needle with double wings - PICC introducer 19G - 1.0mm - L.27mm
Catalog Number
80246.10L
Brand Name
VYGON
Version/Model Number
80246.10L
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
FPA
Product Code Name
Set, administration, intravascular
Public Device Record Key
06fc9317-49cf-4d0d-832d-8802928c052c
Public Version Date
February 06, 2020
Public Version Number
1
DI Record Publish Date
January 29, 2020
Package DI Number
53660812115501
Quantity per Package
24
Contains DI Package
33660812115507
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 | 15 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 195 |