AccessGUDID - DEVICE: INSTRUMENT (07613327221367)

GUDID

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Device Identifier (DI) Information

Brand Name: INSTRUMENT
Version or Model: 6278-9-010
Catalog Number: 6278-9-010
Company Name: Howmedica Osteonics Corp.

Primary DI Number: 07613327221367
Issuing Agency: GS1
Device Count: 1

Device Description: RESTORATION MODULAR INST SYS STRAIGHT DISTAL STEM TRIAL

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
Femoral stem trial prosthesis	A copy of a final femoral stem prosthesis designed to be used for trial reductions during hip arthroplasty to judge the correct offset, leg-length, and range of motion of the final femoral prosthesis to be implanted. It is one of a set of trial hip prostheses that match the different anatomical structures of the hip joint, and is used in conjunction with femoral head trial prostheses. It is typically made of metal or polymer material and includes trial stems and trial necks. This is a reusable device intended to be sterilized prior to use.

GMDN Preferred Term Name

GMDN Definition

Femoral stem trial prosthesis

A copy of a final femoral stem prosthesis designed to be used for trial reductions during hip arthroplasty to judge the correct offset, leg-length, and range of motion of the final femoral prosthesis to be implanted. It is one of a set of trial hip prostheses that match the different anatomical structures of the hip joint, and is used in conjunction with femoral head trial prostheses. It is typically made of metal or polymer material and includes trial stems and trial necks. This is a reusable device intended to be sterilized prior to use.

FDA Product Code

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Product Code	Product Code Name
LXH	ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Sterilization

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

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

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Storage and Handling
No storage/handling found

Clinically Relevant Size

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Size Type Text
Device Size Text, specify: Diameter: 10.0 Millimeter
Length: 127.0 Millimeter

Device Status

Commercial Distribution Status: In Commercial Distribution
DI Record Publish Date: September 24, 2016
Commercial Distribution End Date:

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

Secondary DI

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Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

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DEVICE: INSTRUMENT (07613327221367)