Evolution Revision CCK System ESRF0825

GUDID M684ESRF08251

Knee femur stem prosthesis

Primary Device ID	M684ESRF08251
NIH Device Record Key	bb40db36-58ea-4220-91de-c8945fa4a6fa
Commercial Distribution Status	In Commercial Distribution
Brand Name	Evolution Revision CCK System
Version Model Number	ESRF0825
Catalog Number	ESRF0825
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	M684ESRF08251 [Primary]

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

Steralize Prior To Use	false
Device Is Sterile	true