Control 11F Mechanical Thrombectomy System ASP-1021

GUDID B090ASP10211

General-purpose syringe, single-use

Primary Device ID	B090ASP10211
NIH Device Record Key	c24e9d0f-643e-4a3c-af6b-7845cdbbbddc
Commercial Distribution Status	In Commercial Distribution
Brand Name	Control 11F Mechanical Thrombectomy System
Version Model Number	ASP-1021
Catalog Number	ASP-1021
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	B090ASP10210 [Primary]
HIBCC	B090ASP10211 [Package] Contains: B090ASP10210 Package: Shelf Carton [1 Units] In Commercial Distribution
HIBCC	B090ASP10212 [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