Control 10T Mechanical Thrombectomy System Tubing MT10-100

GUDID B090MT101000

The Control 10T Mechanical Thrombectomy System Tubing is designed to connect a catheter with a female luer lock to an aspiration source. The Control 10T Mechanical Thrombectomy System Tubing is a “tool,” not a “treatment.”

ZIEN MEDICAL TECHNOLOGIES, INC.

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Primary Device IDB090MT101000
NIH Device Record Keyaabcaaff-37fb-43a7-bf1e-c21bef5c41e8
Commercial Distribution StatusIn Commercial Distribution
Brand NameControl 10T Mechanical Thrombectomy System Tubing
Version Model NumberMT10-100
Catalog NumberMT10-100
Company DUNS017535668
Company NameZIEN MEDICAL TECHNOLOGIES, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 Identifiers

Device Issuing AgencyDevice ID
HIBCCB090MT101000 [Primary]
HIBCCB090MT101001 [Package]
Package: Shelf Carton [5 Units]
In Commercial Distribution
HIBCCB090MT101002 [Package]
Contains: B090MT101001
Package: Shipper [2 Units]
In Commercial Distribution

FDA Product Code

BYYTube, Aspirating, Flexible, Connecting

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-11-01
Device Publish Date2022-10-24

Devices Manufactured by ZIEN MEDICAL TECHNOLOGIES, INC.

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