Kalitec Direct InSePtion MIS Fixation System

GUDID B07314IBR00180

Interspinous spinal fixation implant

Primary Device ID	B07314IBR00180
NIH Device Record Key	743a649c-aa4a-4660-af0a-daa8bc62c566
Commercial Distribution Status	In Commercial Distribution
Brand Name	Kalitec Direct InSePtion MIS Fixation System
Version Model Number	14-IBR-0018
Company DUNS	041956211
Company Name	Kalitec Direct LLC
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	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	true
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
HIBCC	B07314IBR00180 [Primary]

PEK	Spinous Process Plate

Steralize Prior To Use	true
Device Is Sterile	false

[B07314IBR00180]

Moist Heat or Steam Sterilization

[B07314IBR00180]

Moist Heat or Steam Sterilization