Duns Number:435428396
Device Description: MectaCem-X LV is a low viscosity polymethylmethacrylate bone cement. It is composed by two MectaCem-X LV is a low viscosity polymethylmethacrylate bone cement. It is composed by two components (40g powder and 13,3g liquid) which are designed for mixing together at the point of use to form the cement. The device is supplied sterile, for single use. MectaCem-X LV is indicated for the fixation of joint prosthesis implants to the host bone.
Catalog Number
-
Brand Name
MectaCem-X LV
Version/Model Number
65.01.103
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
LOD
Product Code Name
Bone Cement
Public Device Record Key
cd580977-acc1-433c-abb3-85aa31ab28d2
Public Version Date
June 17, 2021
Public Version Number
1
DI Record Publish Date
June 09, 2021
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 |