DEVICE: RMA Revolution (07613154169702)

Device Identifier (DI) Information

RMA Revolution
0606600000S1
In Commercial Distribution
0606600000S1
STRYKER CORPORATION
07613154169702
GS1

1
196548481 *Terms of Use
Cement Gun
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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.
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FDA Product Code

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Product Code Product Code Name
KNW INSTRUMENT, BIOPSY
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

No
Yes
Sterilization Method [?]
Ethylene Oxide
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

a1158dae-ca21-4fd7-9ab4-22a9633eb24f
March 29, 2018
2
September 23, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
No
Yes
No
No
No CLOSE

Customer Contact

[?]
+1(800)253-3210
Inst.Stryker.cs@Stryker.com
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