AccessGUDID - DEVICE: INSTRUMENT (07613327214147)

GUDID

Device Identifier (DI) Information

Brand Name: INSTRUMENT
Version or Model: 2210-26C
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 2210-26C
Company Name: Howmedica Osteonics Corp.

Primary DI Number: 07613327214147
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 058311945 *Terms of Use

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

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
Lumen/Inner Diameter: 26.0 Millimeter
Device Size Text, specify: Alpha Code: C
Device Size Text, specify: Degree: 10.0 Degree

Device Record Status

Public Device Record Key: 200778ee-ed4e-42af-af5a-dfd27a6e8cfe
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 24, 2016