LANDMARK LR-N-059

GUDID B090LRN0591

The LANDMARK REBOA catheter is intended for temporary occlusion of large vessels including patients requiring emergency control of hemorrhage.

ZIEN MEDICAL TECHNOLOGIES, INC.

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• Primary Device ID: B090LRN0591
• NIH Device Record Key: e021279a-370c-42d1-b2a1-9ed46d3e57be
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LANDMARK
• Version Model Number: LR-N-059
• Catalog Number: LR-N-059
• Company DUNS: 017535668
• Company Name: ZIEN MEDICAL TECHNOLOGIES, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: true
• 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 Dimensions

• Catheter Working Length: 59 Centimeter
• Introducer Sheath Compatibilit: 7 French
• Catheter Working Length: 59 Centimeter
• Introducer Sheath Compatibilit: 7 French
• Catheter Working Length: 59 Centimeter
• Introducer Sheath Compatibilit: 7 French
• Catheter Working Length: 59 Centimeter
• Introducer Sheath Compatibilit: 7 French
• Catheter Working Length: 59 Centimeter
• Introducer Sheath Compatibilit: 7 French
• Catheter Working Length: 59 Centimeter
• Introducer Sheath Compatibilit: 7 French
• Catheter Working Length: 59 Centimeter
• Introducer Sheath Compatibilit: 7 French
• Catheter Working Length: 59 Centimeter
• Introducer Sheath Compatibilit: 7 French
• Catheter Working Length: 59 Centimeter
• Introducer Sheath Compatibilit: 7 French
• Catheter Working Length: 59 Centimeter
• Introducer Sheath Compatibilit: 7 French
• Catheter Working Length: 59 Centimeter
• Introducer Sheath Compatibilit: 7 French
• Catheter Working Length: 59 Centimeter
• Introducer Sheath Compatibilit: 7 French
• Catheter Working Length: 59 Centimeter
• Introducer Sheath Compatibilit: 7 French
• Catheter Working Length: 59 Centimeter
• Introducer Sheath Compatibilit: 7 French
• Catheter Working Length: 59 Centimeter
• Introducer Sheath Compatibilit: 7 French
• Catheter Working Length: 59 Centimeter
• Introducer Sheath Compatibilit: 7 French
• Catheter Working Length: 59 Centimeter
• Introducer Sheath Compatibilit: 7 French

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B090LRN0590 [Primary]
HIBCC	B090LRN0591 [Package]; Contains: B090LRN0590; Package: Shelf Carton [1 Units]; In Commercial Distribution
HIBCC	B090LRN0592 [Package]; Package: Shipper [5 Units]; In Commercial Distribution

FDA Product Code

• MJN: Catheter, Intravascular Occluding, Temporary

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: 2024-01-31
• Device Publish Date: 2024-01-23

Devices Manufactured by ZIEN MEDICAL TECHNOLOGIES, INC.

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• B090LRN0591 - LANDMARK: 2024-01-31 The LANDMARK REBOA catheter is intended for temporary occlusion of large vessels including patients requiring emergency control
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• B090ASP10211 - Control 11F Mechanical Thrombectomy System: 2023-05-11 The Control 7-11F Mechanical Thrombectomy System and Control Mechanical Aspirator are indicated for the removal of fresh soft em
• B090ASP10331 - Control 7F Mechanical Thrombectomy System: 2023-05-11 The Control 7-11F Mechanical Thrombectomy System and Control Mechanical Aspirator are indicated for the removal of fresh soft em
• B090ASP10361 - Control 11F Mechanical Thrombectomy System: 2023-05-11 The Control 7-11F Mechanical Thrombectomy System and Control Mechanical Aspirator are indicated for the removal of fresh soft em
• B090SPN10051 - SPINR: 2023-05-11 Distal Access torque devices are used to maneuver guidewires in the coronary and peripheral vasculature during interventional or
• B090ASP10011 - Control RX-LP Mechanical Thrombectomy System: 2023-05-04 The Control RX-LP6 Mechanical Thrombectomy Catheter™ and the Control Medical Mechanical Aspirator™ are indicated for the rem
• B090ASP10291 - Control Mechanical Aspirator 30ml: 2023-05-04 The CONTROL MECHANICAL ASPIRATOR is intended to aspirate fluids from the body