AccessGUDID - DEVICE: VariAx (04546540652515)

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Device Identifier (DI) Information

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

Primary DI Number: 04546540652515
Issuing Agency: GS1
Device Count: 1

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

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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	A surgical, jig-like device designed as a preshaped block with a defined pattern of prefabricated holes of various sizes and shapes in it used by the surgeon to guide other instruments [e.g., drill sleeves and guide wires (Kirschner wires)] and to align a corresponding implant (e.g., a fixation plate) during an orthopaedic procedure. It is typically made of high-grade stainless steel or synthetic materials and will typically have a connecting bolt in its centre for attachment to the implant. The surgeon can ascertain the correct placement of the implant and that the bone screws used to fix the plate in place are at the correct angle to the anatomy of the bone. This is a reusable device.

GMDN Preferred Term Name

GMDN Definition

Orthopaedic implant aiming/guiding block

A surgical, jig-like device designed as a preshaped block with a defined pattern of prefabricated holes of various sizes and shapes in it used by the surgeon to guide other instruments [e.g., drill sleeves and guide wires (Kirschner wires)] and to align a corresponding implant (e.g., a fixation plate) during an orthopaedic procedure. It is typically made of high-grade stainless steel or synthetic materials and will typically have a connecting bolt in its centre for attachment to the implant. The surgeon can ascertain the correct placement of the implant and that the bone screws used to fix the plate in place are at the correct angle to the anatomy of the bone. This is a reusable device.

FDA Product Code

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Product Code	Product Code Name
HRS	PLATE, FIXATION, BONE

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 Status

Commercial Distribution Status: In Commercial Distribution
DI Record Publish Date: September 24, 2015
Commercial Distribution End Date:

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
No Secondary DIs found

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DEVICE: VariAx (04546540652515)