Duns Number:119193803
Device Description: Manual Toothbrush, plastic handle with bristles
Catalog Number
7109881
Brand Name
Smilegoods A386 Toothbrush
Version/Model Number
7109881
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
Yes
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
EFW
Product Code Name
Toothbrush, Manual
Public Device Record Key
30e2758e-ffec-4e6f-b8ac-a79b082ffcd0
Public Version Date
July 09, 2021
Public Version Number
1
DI Record Publish Date
July 01, 2021
Package DI Number
00723896019504
Quantity per Package
8
Contains DI Package
00723896019498
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 | 93 |
2 | A medical device with a moderate to high risk that requires special controls. | 2 |