AccessGUDID - DEVICE: Kyocera Medical Technologies, Inc. (00841523105779)

GUDID

Device Identifier (DI) Information

Brand Name: Kyocera Medical Technologies, Inc.
Version or Model: Cemented Hip
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1601-322-100
Company Name: KYOCERA MEDICAL TECHNOLOGIES, INC.

Primary DI Number: 00841523105779
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 116995646 *Terms of Use

Device Description: Distal Centralizer 10mm

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?
34203	Uncoated femoral stem prosthesis, modular	A sterile implantable device designed to replace the proximal femoral neck as part of a total hip arthroplasty (THA). The device is composed of two or more separate segments designed to be joined, is made of metal [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel], and is not coated with materials intended to improve fixation and stability by promoting bone ingrowth. Fixation devices for implantation (e.g., screws and bolts) may be included and implantation is intended to be performed with bone cement.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K141370	000

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
No Device Sizes

Device Record Status

Public Device Record Key: 34ac8c55-3b2e-4b31-8ff5-fdc853e70ef0
Public Version Date: July 23, 2019
Public Version Number: 5
DI Record Publish Date: October 29, 2015