Duns Number:687796909
Device Description: Straumann XenoFlex® is a combination of purified cancellous bone mineral granules (Strauma Straumann XenoFlex® is a combination of purified cancellous bone mineral granules (Straumann Xenograft®) 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
Straumann XenoFlex
Version/Model Number
NI-0110-005
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
1d5c0cf3-9198-4d59-8678-9d9736fd1481
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
October 26, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 102 |