Duns Number:014578892
Device Description: Rest AssuredDental Protector for nightime grinding2 nite protectors, 1 storage case, 1 fit Rest AssuredDental Protector for nightime grinding2 nite protectors, 1 storage case, 1 fitting tray
Catalog Number
-
Brand Name
Rite Aid
Version/Model Number
SQN5483C1
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
OBR
Product Code Name
Mouthguard, Over-The-Counter
Public Device Record Key
640ae5cf-551b-4e97-9370-c686f5078a6d
Public Version Date
October 03, 2022
Public Version Number
1
DI Record Publish Date
September 23, 2022
Package DI Number
20118227688636
Quantity per Package
2
Contains DI Package
10118227688639
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 19 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 7 |
| U | Unclassified | 2 |