LMI CAROTID SHUNT WITH SAFETY BALLOON CATHETER

GUDID B38010FCBS1001020

Carotid artery shunt Carotid artery shunt

Primary Device ID	B38010FCBS1001020
NIH Device Record Key	d8cb9c21-effc-4129-bf62-fd20f95781a8
Commercial Distribution Status	In Commercial Distribution
Brand Name	LMI CAROTID SHUNT WITH SAFETY BALLOON CATHETER
Version Model Number	10FCBS100-10-2
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	B38010FCBS1001020 [Primary]

MJN	Catheter, Intravascular Occluding, Temporary

Steralize Prior To Use	true
Device Is Sterile	true

[B38010FCBS1001020]

Ethylene Oxide

[B38010FCBS1001020]

Ethylene Oxide