DEVICE: RMA Revolution (07613154169702)
Device Identifier (DI) Information
RMA Revolution
0606600000S1
In Commercial Distribution
0606600000S1
STRYKER CORPORATION
0606600000S1
In Commercial Distribution
0606600000S1
STRYKER CORPORATION
Cement Gun
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.
GMDN Preferred Term Name | GMDN Definition |
---|---|
Orthopaedic cement dispensing gun | A hand-operated device designed to hold an orthopaedic cement syringe and to facilitate the dispensing of the cement in the syringe to the application site. It is a pistol-like device with a barrel recess to accept the syringe; upon activation of a handle's trigger at the proximal end of the device, a central piston pushes on the syringe to force cement from its distal end. This is a reusable device. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
KNW | INSTRUMENT, BIOPSY |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
a1158dae-ca21-4fd7-9ab4-22a9633eb24f
March 29, 2018
2
September 23, 2016
March 29, 2018
2
September 23, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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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