AccessGUDID - DEVICE: Initia Total Hip System (04547898304859)

GUDID

Device Identifier (DI) Information

Brand Name: Initia Total Hip System
Version or Model: GMH02-500025
Commercial Distribution Status: In Commercial Distribution
Catalog Number: GMH02-500025
Company Name: KYOCERA CORPORATION

Primary DI Number: 04547898304859
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 690557624 *Terms of Use

Device Description: INITIA STEM STD #7

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 Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
33181	Metal-on-polyethylene total hip prosthesis	A sterile implantable artificial substitute for a diseased (e.g., arthritic) or injured hip joint consisting of matching femoral (head/shaft) and acetabular components articulated at a metal-on-polyethylene or cross-linked polyethylene interface. Fixation devices for implantation (e.g., screws and bolts) may be included and implantation may be performed with or without bone cement.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous 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: 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
Device Size Text, specify: Stem offset: 43mm
Device Size Text, specify: Neck length: 35mm
Device Size Text, specify: Stem length: 111mm
Device Size Text, specify: Taper: 12/14
Device Size Text, specify: Stem: Standard offset
Device Size Text, specify: Size: #7

Device Record Status

Public Device Record Key: f52cf434-7c7b-4e22-a3b3-6e9e7c7116fe
Public Version Date: May 21, 2020
Public Version Number: 4
DI Record Publish Date: February 21, 2017