Control 11F Mechanical Thrombectomy System, 60cm A11-060

GUDID B090A110601

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 General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use General-purpose syringe, single-use
Primary Device IDB090A110601
NIH Device Record Key97b4531a-3a1d-4bc5-a87c-71c3f72e02d6
Commercial Distribution StatusIn Commercial Distribution
Brand NameControl 11F Mechanical Thrombectomy System, 60cm
Version Model NumberA11-060
Catalog NumberA11-060
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 Length60 Centimeter
Catheter Gauge11 French
Catheter Working Length60 Centimeter
Catheter Gauge11 French
Catheter Working Length60 Centimeter
Catheter Gauge11 French
Catheter Working Length60 Centimeter
Catheter Gauge11 French
Catheter Working Length60 Centimeter
Catheter Gauge11 French
Catheter Working Length60 Centimeter
Catheter Gauge11 French
Catheter Working Length60 Centimeter
Catheter Gauge11 French
Catheter Working Length60 Centimeter
Catheter Gauge11 French
Catheter Working Length60 Centimeter
Catheter Gauge11 French
Catheter Working Length60 Centimeter
Catheter Gauge11 French
Catheter Working Length60 Centimeter
Catheter Gauge11 French
Catheter Working Length60 Centimeter
Catheter Gauge11 French
Catheter Working Length60 Centimeter
Catheter Gauge11 French
Catheter Working Length60 Centimeter
Catheter Gauge11 French
Catheter Working Length60 Centimeter
Catheter Gauge11 French
Catheter Working Length60 Centimeter
Catheter Gauge11 French
Catheter Working Length60 Centimeter
Catheter Gauge11 French
Catheter Working Length60 Centimeter
Catheter Gauge11 French

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB090A110600 [Primary]
HIBCCB090A110601 [Package]
Contains: B090A110600
Package: Shelf Carton [1 Units]
In Commercial Distribution
HIBCCB090A110602 [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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