Duns Number:315427286
Device Description: Orthalgenat® Duo, Impression material, berry / 20 x 1 kg
Catalog Number
-
Brand Name
Orthalgenat®
Version/Model Number
150-520-30
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 10, 2020
Issuing Agency
In HIBCC
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
K942666
Product Code
ELW
Product Code Name
MATERIAL, IMPRESSION
Public Device Record Key
60d5f756-55ee-4cf4-bd4a-b3d2bb4eb51d
Public Version Date
March 10, 2020
Public Version Number
4
DI Record Publish Date
May 13, 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 | 2768 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1745 |