SPINR 5X-GW

GUDID B0905XGW1

Distal Access torque devices are used to maneuver guidewires in the coronary and peripheral vasculature during interventional or diagnostic procedures. Distal Access torque devices are not intended for use in the neurovasculature

ZIEN MEDICAL TECHNOLOGIES, INC.

Torque manipulation device Torque manipulation device Torque manipulation device Torque manipulation device Torque manipulation device Torque manipulation device Torque manipulation device Torque manipulation device Torque manipulation device Torque manipulation device Torque manipulation device Torque manipulation device Torque manipulation device Torque manipulation device

• Primary Device ID: B0905XGW1
• NIH Device Record Key: 6c3085a9-d1b7-4cdf-a973-c8e8544044ab
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SPINR
• Version Model Number: 5X-GW
• Catalog Number: 5X-GW
• 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: 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	B0905XGW0 [Primary]
HIBCC	B0905XGW1 [Package]; Contains: B0905XGW0; Package: Shelf Carton [5 Units]; In Commercial Distribution
HIBCC	B0905XGW2 [Package]; Package: Shipper [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141054

FDA Product Code

• DQX: Wire, Guide, Catheter

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: 2022-07-29
• Device Publish Date: 2022-07-21

On-Brand Devices [SPINR]

• B0905XGW1: Distal Access torque devices are used to maneuver guidewires in the coronary and peripheral vasc
• B090SPN10051: Distal Access torque devices are used to maneuver guidewires in the coronary and peripheral vasc