Duns Number:781772017
Device Description: Radiopaque Seps Anterior White Loose Separators 1000/pk
Catalog Number
-
Brand Name
Radiopaque Separators
Version/Model Number
480-305
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
ECI
Product Code Name
BAND, ELASTIC, ORTHODONTIC
Public Device Record Key
264db062-1f74-44e8-8e56-d51e4b42b3da
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
June 28, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 7987 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 663 |