LMI CAROTID SHUNT WITH SAFETY BALLOON CATHETER

GUDID B38011FCBS4004010

Carotid artery shunt

Primary Device ID	B38011FCBS4004010
NIH Device Record Key	216310ce-9d1e-4dc3-8e3e-39f2c761ad2c
Commercial Distribution Status	In Commercial Distribution
Brand Name	LMI CAROTID SHUNT WITH SAFETY BALLOON CATHETER
Version Model Number	11FCBS400-40-1
Company DUNS	878198993
Company Name	LUCAS MEDICAL 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	true
RX Perscription	true
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
HIBCC	B38011FCBS4004010 [Primary]

MJN	Catheter, Intravascular Occluding, Temporary

Steralize Prior To Use	true
Device Is Sterile	true

[B38011FCBS4004010]

Ethylene Oxide

[B38011FCBS4004010]

Ethylene Oxide