Duns Number:033505389
Device Description: BARRIER FILM 4x6 BLUE
Catalog Number
428048
Brand Name
Advance Dental Products
Version/Model Number
428048
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
PEM
Product Code Name
Dental barriers and sleeves
Public Device Record Key
c048922d-8aa0-4971-b9e1-7508e2b3422c
Public Version Date
August 03, 2021
Public Version Number
1
DI Record Publish Date
July 26, 2021
Package DI Number
20850455007505
Quantity per Package
8
Contains DI Package
10850455007508
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 | 10 |
2 | A medical device with a moderate to high risk that requires special controls. | 18 |