AccessGUDID - DEVICE: RMA Revolution (07613154169702)

GUDID

Device Identifier (DI) Information

Brand Name: RMA Revolution
Version or Model: 0606600000S1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 0606600000S1
Company Name: STRYKER CORPORATION

Primary DI Number: 07613154169702
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 196548481 *Terms of Use

Device Description: Cement Gun

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	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.

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

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a1158dae-ca21-4fd7-9ab4-22a9633eb24f
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 23, 2016