Duns Number:483599259
Device Description: Straumann Emdogain Multipack, Straumann Emdogain 3 x 0.3 ml (30 mg/ml), Straumann PrefGel Straumann Emdogain Multipack, Straumann Emdogain 3 x 0.3 ml (30 mg/ml), Straumann PrefGel 3 x 0.6 ml (24% EDTA)
Catalog Number
075.114W
Brand Name
Straumann Emdogain
Version/Model Number
Emdogain
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
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
P930021,P930021
Product Code
NQA
Product Code Name
Biologic Material, Dental
Public Device Record Key
c5be8dbe-9562-420f-985d-fdbc9a6c68f9
Public Version Date
March 14, 2019
Public Version Number
1
DI Record Publish Date
March 06, 2019
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 | 52 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2726 |
| 3 | A medical device with high risk that requires premarket approval | 5 |