Control 10T Mechanical Thrombectomy System Tubing, 3-Pack MT10-100-3

GUDID B090MT1010031

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.

Thrombectomy tubing set, non-electronic

• Primary Device ID: B090MT1010031
• NIH Device Record Key: a5b38c37-45b8-443e-92eb-e8eebfd36180
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Control 10T Mechanical Thrombectomy System Tubing, 3-Pack
• Version Model Number: MT10-100-3
• Catalog Number: MT10-100-3
• Company DUNS: 017535668
• Company Name: ZIEN MEDICAL TECHNOLOGIES, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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 Identifiers

Device Issuing Agency	Device ID
HIBCC	B090MT1010030 [Primary]
HIBCC	B090MT1010031 [Package]; Contains: B090MT1010030; Package: Shelf Carton [5 Units]; In Commercial Distribution
HIBCC	B090MT1010032 [Package]; Package: Shipper [2 Units]; In Commercial Distribution

FDA Product Code

• BYY: Tube, Aspirating, Flexible, Connecting

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-11-01
• Device Publish Date: 2022-10-24

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