Duns Number:008965063
Device Description: Dental Tool Kit, 1 Dental Scaler, 1 Mirror, 1 Dental Pick, and 1 Tongue Cleaner
Catalog Number
-
Brand Name
Walgreens
Version/Model Number
203666
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
EAX
Product Code Name
Mirror, Mouth
Public Device Record Key
627faa84-2a29-46b4-b298-ee7a315bdcad
Public Version Date
January 08, 2021
Public Version Number
2
DI Record Publish Date
May 28, 2020
Package DI Number
10311917197378
Quantity per Package
72
Contains DI Package
00311917197371
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 |