Duns Number:989365556
Device Description: Smartset GHV GENTAMICIN High Viscosity Bone Cement 40g
Catalog Number
545035500
Brand Name
SMARTSET
Version/Model Number
5450-35-500
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
K023012,K081163,K061144,K053445,K053002,K033563,K033382,K023012,K023012,K033382,K033563,K053002,K053445,K061144,K081163,K033563,K053002,K053445,K061144,K081163,K033382
Product Code
JDZ
Product Code Name
MIXER, CEMENT, FOR CLINICAL USE
Public Device Record Key
c9b59e8b-26c7-41df-9abb-d71c49276736
Public Version Date
June 19, 2020
Public Version Number
5
DI Record Publish Date
September 24, 2015
Package DI Number
20603295174285
Quantity per Package
10
Contains DI Package
10603295174288
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 |