Evolution Revision CCK System EFCCN8RL

GUDID M684EFCCN8RL1

Uncoated knee femur prosthesis, metallic

Primary Device ID	M684EFCCN8RL1
NIH Device Record Key	199d2954-8982-4ebe-9a7c-598451e44ba8
Commercial Distribution Status	In Commercial Distribution
Brand Name	Evolution Revision CCK System
Version Model Number	EFCCN8RL
Catalog Number	EFCCN8RL
Company DUNS	079118736
Company Name	Microport Orthopedics Inc.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	true
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Phone	+1(866)872-0211
Email	Stephen.Weaver@ortho.microport.com

Device Issuing Agency	Device ID
HIBCC	M684EFCCN8RL1 [Primary]

JWH	PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER

Steralize Prior To Use	false
Device Is Sterile	true