Duns Number:300537672
Device Description: SET of total 8 pcs OCCLUSIONS (1x edelweiss OCCLUSION 17 S, 1x edelweiss OCCLUSION 16 S, SET of total 8 pcs OCCLUSIONS (1x edelweiss OCCLUSION 17 S, 1x edelweiss OCCLUSION 16 S, 1x edelweiss OCCLUSION 15 S, 1x edelweiss OCCLUSION 14 S, 1x edelweiss OCCLUSION 24 S, 1x edelweiss OCCLUSION 25 S, 1x edelweiss OCCLUSION 26 S, 1x edelweiss OCCLUSION 27 )
Catalog Number
-
Brand Name
edelweiss OCCLUSION SET 17-27 S up
Version/Model Number
13170
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
EBF
Product Code Name
Material, Tooth Shade, Resin
Public Device Record Key
fe196e05-105a-4cfd-aab8-76f1ce32d0c1
Public Version Date
February 05, 2021
Public Version Number
2
DI Record Publish Date
May 09, 2018
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 145 |