Duns Number:196548481
Device Description: Cement Mixing System with MIS Femoral Breakaway Nozzle
Catalog Number
0606565000
Brand Name
Revolution
Version/Model Number
0606565000
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
JDZ
Product Code Name
MIXER, CEMENT, FOR CLINICAL USE
Public Device Record Key
e00c3a17-09cd-47c0-9f52-0ea80fbcb475
Public Version Date
October 25, 2018
Public Version Number
1
DI Record Publish Date
September 24, 2018
Package DI Number
37613154169673
Quantity per Package
6
Contains DI Package
07613154169672
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
pack
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2188 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3183 |
| U | Unclassified | 60 |