Duns Number:008965063
Device Description: READY TO WEAR DENTAL GUARD 16 CT.
Catalog Number
-
Brand Name
Walgreens
Version/Model Number
508933
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)
-
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
fbee6509-e032-4a19-a641-6dde43122a9d
Public Version Date
December 21, 2020
Public Version Number
2
DI Record Publish Date
May 28, 2020
Package DI Number
10311917211357
Quantity per Package
48
Contains DI Package
00311917211350
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 | 75 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 74 |
| U | Unclassified | 2 |