Duns Number:435428396
Device Description: Cemex Genta System 80g is an antibiotic-loaded polymethylmethacrylate bone cement. Cemex G Cemex Genta System 80g is an antibiotic-loaded polymethylmethacrylate bone cement. Cemex Genta System 80g holds the powder (80g) and liquid (29,3g) components separately within a closed syringe-like device that serves as both a mixing chamber and a cement delivery system. The device is supplied sterile, for single use.Cemex Genta System 80g is indicated for the fixation of prostheses to living bone in the second stage of a two-stage revision for total joint arthroplasty after the initial infection has been cleared.
Catalog Number
-
Brand Name
CEMEX GENTA SYSTEM 80G
Version/Model Number
1500/SG US
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
-
Product Code
LOD
Product Code Name
Bone Cement
Public Device Record Key
2131a00b-8753-4432-8a6d-91addb5f1e5e
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
October 07, 2015
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 | 37 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 52 |