High Viscosity Injection System T060421

GUDID 03760177043107

Orthopaedic cement preparation/delivery kit

Primary Device ID	03760177043107
NIH Device Record Key	28e6adc7-4d73-4d32-95af-99dbe3d1178a
Commercial Distribution Status	In Commercial Distribution
Brand Name	High Viscosity Injection System
Version Model Number	T060421
Catalog Number	T060421
Company DUNS	764746723
Company Name	TEKNIMED
Device Count	1
DM Exempt	false
Pre-market Exempt	true
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

Device Issuing Agency	Device ID
GS1	03760177043107 [Primary]

OAR	Injector, Vertebroplasty (Does Not Contain Cement)

Steralize Prior To Use	false
Device Is Sterile	true