MULTIGEN PLUS Knee 9066.64.010

GUDID 08033390084123

Balancer

LIMACORPORATE SPA

Orthopaedic knee-balance analyser, non-electrical Orthopaedic knee-balance analyser, non-electrical Orthopaedic knee-balance analyser, non-electrical Orthopaedic knee-balance analyser, non-electrical Orthopaedic knee-balance analyser, non-electrical Orthopaedic knee-balance analyser, non-electrical Orthopaedic knee-balance analyser, non-electrical Orthopaedic knee-balance analyser, non-electrical Orthopaedic knee-balance analyser, non-electrical Orthopaedic knee-balance analyser, non-electrical Orthopaedic knee-balance analyser, non-electrical

Primary Device ID	08033390084123
NIH Device Record Key	763e7234-fa06-4fc1-be59-b95c403dc689
Commercial Distribution Status	In Commercial Distribution
Brand Name	MULTIGEN PLUS Knee
Version Model Number	Balancer
Catalog Number	9066.64.010
Company DUNS	432066322
Company Name	LIMACORPORATE SPA
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	false
Lot Batch	true
Serial Number	false
Manufacturing Date	false
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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08033390084123 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K151266

FDA Product Code

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