Catalog Number
-
Brand Name
Plackers
Version/Model Number
UWB
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
JES
Product Code Name
Floss, Dental
Public Device Record Key
0c14c0cf-1533-40b8-9c32-fc8db98a27f6
Public Version Date
May 28, 2020
Public Version Number
1
DI Record Publish Date
May 20, 2020
Package DI Number
10651080125519
Quantity per Package
3
Contains DI Package
00651080125512
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-