Duns Number:120818216
Device Description: 8CM LEADERFLEX BASIC INSERTION TRAY
Catalog Number
VYLF1008
Brand Name
VYGON
Version/Model Number
VYLF1008
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
K141026,K141026
Product Code
FOZ
Product Code Name
Catheter, intravascular, therapeutic, short-term less than 30 days
Public Device Record Key
779141ab-f566-4c62-bd3f-b31f5e82cd95
Public Version Date
February 19, 2021
Public Version Number
2
DI Record Publish Date
October 29, 2019
Package DI Number
30849884004404
Quantity per Package
10
Contains DI Package
00849884004403
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 |