Control 9F Mechanical Thrombectomy System, 60cm A9-060

GUDID B090A90601

General-purpose syringe, single-use

Primary Device ID	B090A90601
NIH Device Record Key	cf3f70f8-5e46-4b93-86c8-0fcdbc618282
Commercial Distribution Status	In Commercial Distribution
Brand Name	Control 9F Mechanical Thrombectomy System, 60cm
Version Model Number	A9-060
Catalog Number	A9-060
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	B090A90600 [Primary]
HIBCC	B090A90601 [Package] Contains: B090A90600 Package: Shelf Carton [1 Units] In Commercial Distribution
HIBCC	B090A90602 [Package] Package: Shipper [9 Units] In Commercial Distribution

QEZ	Aspiration Thrombectomy Catheter

Steralize Prior To Use	false
Device Is Sterile	true

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