Control 9F Mechanical Thrombectomy System, 60cm

FDA UDI

Class II (US FDA UDI)

by ZIEN Medical Technologies, LLC

Identity

Trade Name: Control 9F Mechanical Thrombectomy System, 60cm FDA UDI
Generic Name: General-purpose syringe, single-use FDA UDI
Device Name: 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. FDA UDI
Model / Reference: A9-060 FDA UDI
Description: 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. FDA UDI

Identifiers

Catalog Number: A9-060 FDA UDI
Primary DI / UDI-DI: B090A90600 FDA UDI
FDA Product Code: QEZ FDA UDI
GMDN Term: General-purpose syringe, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 870.5150 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Catheter Working Length — 60 Centimeter FDA UDI
Catheter Gauge — 9 French FDA UDI

Category: General-purpose syringe, single-use Thrombectomy suction catheter

Control 9F Mechanical Thrombectomy System, 60cm by ZIEN Medical Technologies, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: ZIEN Medical Technologies, LLC

Sources (1)

FDA UDI cf3f70f8-5e46-4b93-86c8-0fcdbc618282 35 fields · synced May 30, 2026