Duns Number:868856969
Device Description: Vilet II Quick PGA 4/0 FS-2 [3/8C RevCt 19mm] 18" Undyed
Catalog Number
VGQ392
Brand Name
Vilet II Quick™
Version/Model Number
VGQ392
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
GAM
Product Code Name
Suture, Absorbable, Synthetic, Polyglycolic Acid
Public Device Record Key
79d3dc1f-c8e9-4a61-9770-153d7a3b1f39
Public Version Date
October 17, 2022
Public Version Number
4
DI Record Publish Date
October 16, 2015
Package DI Number
20841307130656
Quantity per Package
12
Contains DI Package
10841307130659
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Chipboard Carton
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 328 |
2 | A medical device with a moderate to high risk that requires special controls. | 1817 |
U | Unclassified | 6 |