Duns Number:196548481
Device Description: Cement Mixing System with Femoral Breakaway Nozzle, Medium Solid Proximal Pressurizer, Rev Cement Mixing System with Femoral Breakaway Nozzle, Medium Solid Proximal Pressurizer, Revision Cement Restrictor, Small and Universal Cement Restrictor
Catalog Number
0606-705-000S1
Brand Name
Revolution
Version/Model Number
0606705000S1
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
OAR
Product Code Name
Injector, vertebroplasty (does not contain cement)
Public Device Record Key
65d2d4fd-3858-47a5-b485-15a4f608ab25
Public Version Date
November 05, 2020
Public Version Number
2
DI Record Publish Date
September 24, 2018
Package DI Number
37613154354390
Quantity per Package
6
Contains DI Package
07613154354399
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 |