Duns Number:989365556
Device Description: SmartSet HIGH PERFORMANCE MV Medium Viscosity Bone Cement 20g
Catalog Number
3122020
Brand Name
SMARTSET
Version/Model Number
3122-020
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
K081155,K081155,K081155
Product Code
LOD
Product Code Name
BONE CEMENT
Public Device Record Key
6513c128-9aab-4b83-a730-148d235b1953
Public Version Date
June 19, 2020
Public Version Number
5
DI Record Publish Date
September 24, 2015
Package DI Number
20603295168369
Quantity per Package
10
Contains DI Package
10603295168362
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
PACKAGE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 3549 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2188 |
| 3 | A medical device with high risk that requires premarket approval | 418 |