AccessGUDID - DEVICE: Trident (04546540516848)

GUDID

Device Identifier (DI) Information

Brand Name: Trident
Version or Model: 625-0T-32E
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 625-0T-32E
Company Name: Howmedica Osteonics Corp.

Primary DI Number: 04546540516848
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 058311945 *Terms of Use

Device Description: Alpha Code E

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:	Yes
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
Ceramic acetabular liner	A sterile implantable inner component of a two-piece acetabulum prosthesis that is inserted into an acetabular shell prosthesis to provide the articulating surface with a femoral head prosthesis as part of a total hip arthroplasty (THA). It is made of ceramic material (e. g alumina).

FDA Product Code

[?]

Product Code	Product Code Name
MRA	Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P000013	001
P000013	002
P000013	003
P000013	004
P000013	005
P000013	006
P000013	008
P000013	009
P000013	010
P000013	011
P000013	012
P000013	015
P000013	016

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Lumen/Inner Diameter: 32.0 Millimeter
Device Size Text, specify: Degree: 0.0 Degree

Device Record Status

Public Device Record Key: 7c880dd1-839d-406f-9b53-912933807ae7
Public Version Date: January 07, 2019
Public Version Number: 5
DI Record Publish Date: October 03, 2014