Zurich Pressure Guidewire System 308

GUDID 00850022994005

ZURICH MEDICAL INC.

Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use Cardiac/peripheral vascular guidewire, single-use

• Primary Device ID: 00850022994005
• NIH Device Record Key: b9a51682-4c3b-4613-84d8-41451ffa0c3e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Zurich Pressure Guidewire System
• Version Model Number: Model 100
• Catalog Number: 308
• Company DUNS: 080001248
• Company Name: ZURICH MEDICAL 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
GS1	00850022994005 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190852

FDA Product Code

• DXO: Transducer, Pressure, Catheter Tip

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: 2020-09-29
• Device Publish Date: 2020-09-21

Devices Manufactured by ZURICH MEDICAL INC.

• 00850022994265 - Zurich Medical Accessory Cable: 2023-04-21
• 00850022994272 - Zurich Medical Accessory Cable: 2023-04-21
• 00850022994289 - Zurich Medical Accessory Cable: 2023-04-21
• 00850022994296 - Zurich Medical Accessory Cable: 2023-04-21
• 00850022994326 - Zurich Medical Accessory Cable: 2023-04-21
• 00850022994333 - Zurich Medical Accessory Cable: 2023-04-21
• 00850022994340 - Zurich Medical Accessory Cable: 2023-04-21
• 00850022994357 - Zurich Medical Accessory Cable: 2023-04-21