DEVICE: Revolution (07613154169665)
Device Identifier (DI) Information
Revolution
0606553000S1
In Commercial Distribution
0606553000S1
STRYKER CORPORATION
0606553000S1
In Commercial Distribution
0606553000S1
STRYKER CORPORATION
Cement Mixing System with Nozzle
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
47737 | Orthopaedic cement injection cannula |
A sterile, semi-rigid or rigid tube that is attached to the distal end of an orthopaedic cement dispenser and through which the bone cement is precisely extruded (dispensed) from the dispenser to the target site. It is typically made of plastic material. This is a single-use device.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
JDZ | MIXER, CEMENT, FOR CLINICAL USE |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
Angle: 65.0 degree |
Device Record Status
92520834-df68-48e0-aaec-fc9b9bdaa13b
October 25, 2018
1
September 24, 2018
October 25, 2018
1
September 24, 2018
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
37613154169666 | 6 | 07613154169665 | In Commercial Distribution | pack |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)253-3210
Inst.Stryker.cs@Stryker.com
Inst.Stryker.cs@Stryker.com