Duns Number:092364462
Catalog Number
-
Brand Name
AVID TRUCUSTOM
Version/Model Number
VAMM046-01
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 03, 2019
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"
Yes
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
KDD
Product Code Name
Kit, surgical instrument, disposable
Public Device Record Key
4688bf80-3f31-4904-a0e0-d2f851f927fa
Public Version Date
June 17, 2022
Public Version Number
6
DI Record Publish Date
October 12, 2016
Package DI Number
20809160109981
Quantity per Package
50
Contains DI Package
10809160109984
Package Discontinue Date
April 03, 2019
Package Status
Not 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 | 548 |
2 | A medical device with a moderate to high risk that requires special controls. | 2798 |
U | Unclassified | 1 |