AccessGUDID - DEVICE: CentLoc Total Knee System (08800036800207)

GUDID

Device Identifier (DI) Information

Brand Name: CentLoc Total Knee System
Version or Model: 7111-5963R
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 7111-5963R
Company Name: RootLoc Co., Ltd.

Primary DI Number: 08800036800207
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 694670830 *Terms of Use

Device Description: CentLoc Femoral component PS type Right Size4

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):	No
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?
61559	Femur/tibia shaft prosthesis	A sterile implantable device designed to replace the shaft (body) of the femur/tibia following resection of the femur/tibia (e.g., due to tumour). It typically connects proximally to a femoral stem prosthesis or knee tibia prosthesis and distally to a sleeve femoral/tibial extension, knee femur prosthesis, or body femoral/tibial extension stem; it is made of metal [e.g., cobalt-chrome (Co-Cr), titanium (Ti), stainless steel]. Disposable devices associated with implantation may be included.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K182370	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: c773b1f5-a024-4018-88df-490944817e56
Public Version Date: September 25, 2019
Public Version Number: 1
DI Record Publish Date: September 17, 2019