Duns Number:092364462
Catalog Number
-
Brand Name
AVID TRUCUSTOM
Version/Model Number
VAMM036-02
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 23, 2018
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)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
NSB
Product Code Name
Patient personal hygiene kit
Public Device Record Key
2239b1d5-913f-4c10-817a-4bf7f3a367f4
Public Version Date
January 01, 2019
Public Version Number
3
DI Record Publish Date
April 04, 2017
Package DI Number
20809160144180
Quantity per Package
20
Contains DI Package
10809160144183
Package Discontinue Date
May 23, 2018
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 |