Duns Number:196548481
Device Description: Cement Mixing System with Femoral Breakaway Nozzle, Medium Solid Proximal Pressurizer, Uni Cement Mixing System with Femoral Breakaway Nozzle, Medium Solid Proximal Pressurizer, Universal Cement Restrictor with Disposable Inserter and Small Cement Restrictor
Catalog Number
0606-705-000
Brand Name
Revolution
Version/Model Number
0606705000
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
3ce5ccbf-09db-4429-9077-9a1c8321be17
Public Version Date
November 05, 2020
Public Version Number
3
DI Record Publish Date
January 16, 2018
Package DI Number
34546540912344
Quantity per Package
6
Contains DI Package
04546540912343
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 |