Duns Number:687796909
Device Description: Creos Xenogain Collagen is a combination of purified cancellous bone mineral granules (Cre Creos Xenogain Collagen is a combination of purified cancellous bone mineral granules (Creos Xenogain) and 10% collagen in a block form in a blister and cylindrical form in a syringe and blister. It is sterilized by γ- irradiation.
Catalog Number
-
Brand Name
Creos Xenogain Collagen
Version/Model Number
N1310
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
K142040
Product Code
NPM
Product Code Name
Bone Grafting Material, Animal Source
Public Device Record Key
4ea400ae-d7a4-42e5-9702-8c1e7f4a8475
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 23, 2016
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. | 102 |