AccessGUDID - DEVICE: VariAx (04546540652515)

GUDID

Device Identifier (DI) Information

Brand Name: VariAx
Version or Model: 56-01710
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 56-01710
Company Name: Stryker Trauma SA

Primary DI Number: 04546540652515
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 481999654 *Terms of Use

Device Description: VOLAR DR AIMING BLOCK, STANDARD, LEFT

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 implant aiming/guiding block, reusable	A surgical, jig-like device designed as a preshaped block with a defined pattern of prefabricated holes used to guide other instruments [e.g., drill sleeves and guide wires (Kirschner wires)] and/or to align a corresponding implant (e.g., a fixation plate) during an orthopaedic procedure. It is typically made of metallic or synthetic materials and may have an attachment point for an implant. This is a reusable device.

GMDN Preferred Term Name

GMDN Definition

Orthopaedic implant aiming/guiding block, reusable

A surgical, jig-like device designed as a preshaped block with a defined pattern of prefabricated holes used to guide other instruments [e.g., drill sleeves and guide wires (Kirschner wires)] and/or to align a corresponding implant (e.g., a fixation plate) during an orthopaedic procedure. It is typically made of metallic or synthetic materials and may have an attachment point for an implant. This is a reusable device.

FDA Product Code

[?]

Product Code	Product Code Name
HRS	PLATE, FIXATION, BONE

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 [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Number of Screw Holes: 7.0 Holes

Device Record Status

Public Device Record Key: 25688737-52c8-47ad-a40c-2270f0e235ea
Public Version Date: September 24, 2018
Public Version Number: 3
DI Record Publish Date: September 24, 2015