Duns Number:300537672
Device Description: SET of total 8 pcs OCCLUSIONS (1x edelweiss OCCLUSION 47 L, 1x edelweiss OCCLUSION 46 L, SET of total 8 pcs OCCLUSIONS (1x edelweiss OCCLUSION 47 L, 1x edelweiss OCCLUSION 46 L, 1x edelweiss OCCLUSION 45 L, 1x edelweiss OCCLUSION 44 L, 1x edelweiss OCCLUSION 34 L, 1x edelweiss OCCLUSION 35 L, 1x edelweiss OCCLUSION 36 L, 1x edelweiss OCCLUSION 37 L)
Catalog Number
-
Brand Name
edelweiss OCCLUSION SET 47-37 L low
Version/Model Number
13195
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
a98f06e9-62dc-4867-a30e-528a2314a274
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 |