Control 9F Mechanical Thrombectomy System, 90cm A9-090

GUDID B090A90901

The Control 7-11F Mechanical Thrombectomy System and Control Mechanical Aspirator are indicated for the removal of fresh soft emboli and thrombi from vessels in the peripheral vasculature.

ZIEN MEDICAL TECHNOLOGIES, INC.

General-purpose syringe, single-use
Primary Device IDB090A90901
NIH Device Record Keyd9d4eb60-4de9-47df-930d-90f710c9abae
Commercial Distribution StatusIn Commercial Distribution
Brand NameControl 9F Mechanical Thrombectomy System, 90cm
Version Model NumberA9-090
Catalog NumberA9-090
Company DUNS017535668
Company NameZIEN MEDICAL TECHNOLOGIES, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Catheter Working Length90 Centimeter
Catheter Gauge9 French
Catheter Working Length90 Centimeter
Catheter Gauge9 French
Catheter Working Length90 Centimeter
Catheter Gauge9 French
Catheter Working Length90 Centimeter
Catheter Gauge9 French
Catheter Working Length90 Centimeter
Catheter Gauge9 French
Catheter Working Length90 Centimeter
Catheter Gauge9 French
Catheter Working Length90 Centimeter
Catheter Gauge9 French
Catheter Working Length90 Centimeter
Catheter Gauge9 French
Catheter Working Length90 Centimeter
Catheter Gauge9 French
Catheter Working Length90 Centimeter
Catheter Gauge9 French
Catheter Working Length90 Centimeter
Catheter Gauge9 French
Catheter Working Length90 Centimeter
Catheter Gauge9 French
Catheter Working Length90 Centimeter
Catheter Gauge9 French
Catheter Working Length90 Centimeter
Catheter Gauge9 French
Catheter Working Length90 Centimeter
Catheter Gauge9 French
Catheter Working Length90 Centimeter
Catheter Gauge9 French
Catheter Working Length90 Centimeter
Catheter Gauge9 French
Catheter Working Length90 Centimeter
Catheter Gauge9 French

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB090A90900 [Primary]
HIBCCB090A90901 [Package]
Contains: B090A90900
Package: Shelf Carton [1 Units]
In Commercial Distribution
HIBCCB090A90902 [Package]
Package: Shipper [9 Units]
In Commercial Distribution

FDA Product Code

QEZAspiration Thrombectomy Catheter

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-07-07
Device Publish Date2022-06-29

Devices Manufactured by ZIEN MEDICAL TECHNOLOGIES, INC.

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