Duns Number:486711679
Device Description: TRAUMACEM(TM) V+ INJECTABLE BONE CEMENT - STERILE
Catalog Number
07702040S
Brand Name
TRAUMACEM
Version/Model Number
07.702.040S
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
K170802
Product Code
LOD
Product Code Name
BONE CEMENT
Public Device Record Key
b0316504-c1dc-4f5c-8ec7-6f6456129153
Public Version Date
May 02, 2022
Public Version Number
5
DI Record Publish Date
October 06, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 8630 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 16671 |
| U | Unclassified | 2 |