Duns Number:668367758
Device Description: Mouth Guard Box
Catalog Number
-
Brand Name
Premium Plus
Version/Model Number
601-LB
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
NNI
Product Code Name
Container, Specimen, Non-Sterile
Public Device Record Key
f0e7c07c-0162-47bd-a711-25f77d83e717
Public Version Date
January 07, 2020
Public Version Number
1
DI Record Publish Date
December 30, 2019
Package DI Number
D838601LB8
Quantity per Package
20
Contains DI Package
D838601LB2
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 166 |
2 | A medical device with a moderate to high risk that requires special controls. | 13 |