Duns Number:344261631
Device Description: Simplex® HV with Gentamicin is a fast-setting acrylic resin with addition of gentamicin su Simplex® HV with Gentamicin is a fast-setting acrylic resin with addition of gentamicin sulfate for use in bone surgery. Mixing the two separate sterile components produces a ductile bone cement which, after hardening, fixes the implant and transfers stresses produced during movement evenly to the bone. Simplex® HV with Gentamicinn cement powder also contains insoluble zirconium dioxide as an X-ray contrast medium. Simplex® HV with Gentamicin does not emit a signal and does not pose a safety risk in a magnetic resonance environment.
Catalog Number
6195-1-010
Brand Name
Simplex HV with Gentamicin
Version/Model Number
6195-1-001
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
fecad468-9d2e-4241-80de-6c548421c6f4
Public Version Date
June 19, 2020
Public Version Number
4
DI Record Publish Date
September 24, 2015
Package DI Number
24260056885765
Quantity per Package
2
Contains DI Package
14260056885768
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Shipping unit
| 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. | 4 |