Control 11F Mechanical Thrombectomy System A11-090

GUDID B090A110901

General-purpose syringe, single-use

Primary Device ID	B090A110901
NIH Device Record Key	41c400dc-af3c-4fda-bd2f-2993428238fb
Commercial Distribution Status	In Commercial Distribution
Brand Name	Control 11F Mechanical Thrombectomy System
Version Model Number	A11-090
Catalog Number	A11-090
Company DUNS	017535668
Company Name	ZIEN MEDICAL TECHNOLOGIES, 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	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 Issuing Agency	Device ID
HIBCC	B090A110900 [Primary]
HIBCC	B090A110901 [Package] Contains: B090A110900 Package: Shelf Carton [1 Units] In Commercial Distribution
HIBCC	B090A110902 [Package] Package: Shipper [9 Units] In Commercial Distribution

QEZ	Aspiration Thrombectomy Catheter

Steralize Prior To Use	false
Device Is Sterile	true

B090A110901	The Control 7-11F Mechanical Thrombectomy System and Control Mechanical Aspirator are indicated
B090ASP10361	The Control 7-11F Mechanical Thrombectomy System and Control Mechanical Aspirator are indicated
B090ASP10211	The Control 7-11F Mechanical Thrombectomy System and Control Mechanical Aspirator are indicated