Duns Number:424382307
Device Description: geneX® is a simple to use synthetic resorbable material designed to promote regeneration o geneX® is a simple to use synthetic resorbable material designed to promote regeneration of bone in osseous defects. It degrades into component elements normally found in the body and is highly biocompatible.The kit contains a powder and mixing solution which, when combined, provides a mouldable cohesive paste for introduction into a syringe. When injected the mixture sets to form geneX® a hard but resorbable matrix. geneX® is supplied sterile
Catalog Number
900-005
Brand Name
geneX®
Version/Model Number
900-005
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
-
Product Code
MQV
Product Code Name
Filler, Bone Void, Calcium Compound
Public Device Record Key
1dd2d933-c9ca-466d-b2e6-9ee4b3c47e77
Public Version Date
January 15, 2020
Public Version Number
1
DI Record Publish Date
January 07, 2020
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 | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 89 |