AccessGUDID - DEVICE: INSTRUMENT (07613327012378)

GUDID

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Device Identifier (DI) Information

Brand Name: INSTRUMENT
Version or Model: 2208-6077L
Catalog Number: 2208-6077L
Company Name: Howmedica Osteonics Corp.

Primary DI Number: 07613327012378
Issuing Agency: GS1
Device Count: 1

Device Description: RESTORATION ANATOMIC SHELL 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
Acetabulum trial prosthesis, reusable	A copy of a final acetabular prosthesis designed to be used for trial reductions during hip arthroplasty to judge the correct size and position of the final acetabular prosthesis to be implanted. It is one of a set of trial hip prostheses that match the different anatomical structures of the hip joint. It is typically made of metal or polymer material and may be designed in the form of cages, shells, augments, or inserts. This is a reusable device intended to be sterilized prior to use.

GMDN Preferred Term Name

GMDN Definition

Acetabulum trial prosthesis, reusable

A copy of a final acetabular prosthesis designed to be used for trial reductions during hip arthroplasty to judge the correct size and position of the final acetabular prosthesis to be implanted. It is one of a set of trial hip prostheses that match the different anatomical structures of the hip joint. It is typically made of metal or polymer material and may be designed in the form of cages, shells, augments, or inserts. This is a reusable device intended to be sterilized prior to use.

FDA Product Code

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Product Code	Product Code Name
LPH	PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED
MEH	Prosthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate
HWC	Screw, fixation, bone
KWZ	Prosthesis, hip, constrained, cemented or uncemented, metal/polymer
KWY	Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
LZO	Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented
KWL	Prosthesis, hip, hemi-, femoral, metal
MAY	Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous cemented, osteophilic finish
MBL	Prosthesis, hip, semi-constrained, uncemented, metal/polymer, porous
JDI	Prosthesis, hip, semi-constrained, metal/polymer, cemented
LWJ	Prosthesis, hip, semi-constrained, metal/polymer, uncemented

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
Outer Diameter: 77.0 Millimeter
Device Size Text, specify: Side: LEFT

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 (07613327012378)