Duns Number:050193715
Device Description: VGCTR03 INTRODUCER SET
Catalog Number
VGCTR03
Brand Name
INTRODUCER SET
Version/Model Number
VGCTR03
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
K180178
Product Code
DYB
Product Code Name
Introducer, Catheter
Public Device Record Key
1f976e29-6cea-4a5f-a21e-2d15f2e4012b
Public Version Date
June 07, 2019
Public Version Number
2
DI Record Publish Date
December 20, 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 | 5 |
2 | A medical device with a moderate to high risk that requires special controls. | 20 |