TriGuide Guiding Catheter

GUDID 00857136004255

TriSalus TriGuide Guiding Catheter, 5F, Simmons 1 (SIM1) Shape, 0.048" ID, 65cm Usable Length

SUREFIRE MEDICAL, INC.

Vascular guide-catheter, single-use

• Primary Device ID: 00857136004255
• NIH Device Record Key: 3f494232-1cce-4a3c-8fc0-14f1660802ba
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TriGuide Guiding Catheter
• Version Model Number: TGC-04865-Sim1
• Company DUNS: 832575497
• Company Name: SUREFIRE 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Catheter Gauge: 5 French
• Catheter Working Length: 65 Centimeter
• Catheter Inner Diameter: 0.048 Inch
• Catheter Gauge: 5 French
• Catheter Working Length: 65 Centimeter
• Catheter Inner Diameter: 0.048 Inch
• Catheter Gauge: 5 French
• Catheter Working Length: 65 Centimeter
• Catheter Inner Diameter: 0.048 Inch
• Catheter Gauge: 5 French
• Catheter Working Length: 65 Centimeter
• Catheter Inner Diameter: 0.048 Inch
• Catheter Gauge: 5 French
• Catheter Working Length: 65 Centimeter
• Catheter Inner Diameter: 0.048 Inch
• Catheter Gauge: 5 French
• Catheter Working Length: 65 Centimeter
• Catheter Inner Diameter: 0.048 Inch
• Catheter Gauge: 5 French
• Catheter Working Length: 65 Centimeter
• Catheter Inner Diameter: 0.048 Inch
• Catheter Gauge: 5 French
• Catheter Working Length: 65 Centimeter
• Catheter Inner Diameter: 0.048 Inch
• Catheter Gauge: 5 French
• Catheter Working Length: 65 Centimeter
• Catheter Inner Diameter: 0.048 Inch
• Catheter Gauge: 5 French
• Catheter Working Length: 65 Centimeter
• Catheter Inner Diameter: 0.048 Inch
• Catheter Gauge: 5 French
• Catheter Working Length: 65 Centimeter
• Catheter Inner Diameter: 0.048 Inch
• Catheter Gauge: 5 French
• Catheter Working Length: 65 Centimeter
• Catheter Inner Diameter: 0.048 Inch
• Catheter Gauge: 5 French
• Catheter Working Length: 65 Centimeter
• Catheter Inner Diameter: 0.048 Inch
• Catheter Gauge: 5 French
• Catheter Working Length: 65 Centimeter
• Catheter Inner Diameter: 0.048 Inch
• Catheter Gauge: 5 French
• Catheter Working Length: 65 Centimeter
• Catheter Inner Diameter: 0.048 Inch
• Catheter Gauge: 5 French
• Catheter Working Length: 65 Centimeter
• Catheter Inner Diameter: 0.048 Inch
• Catheter Gauge: 5 French
• Catheter Working Length: 65 Centimeter
• Catheter Inner Diameter: 0.048 Inch
• Catheter Gauge: 5 French
• Catheter Working Length: 65 Centimeter
• Catheter Inner Diameter: 0.048 Inch
• Catheter Gauge: 5 French
• Catheter Working Length: 65 Centimeter
• Catheter Inner Diameter: 0.048 Inch
• Catheter Gauge: 5 French
• Catheter Working Length: 65 Centimeter
• Catheter Inner Diameter: 0.048 Inch
• Catheter Gauge: 5 French
• Catheter Working Length: 65 Centimeter
• Catheter Inner Diameter: 0.048 Inch
• Catheter Gauge: 5 French
• Catheter Working Length: 65 Centimeter
• Catheter Inner Diameter: 0.048 Inch
• Catheter Gauge: 5 French
• Catheter Working Length: 65 Centimeter
• Catheter Inner Diameter: 0.048 Inch
• Catheter Gauge: 5 French
• Catheter Working Length: 65 Centimeter
• Catheter Inner Diameter: 0.048 Inch
• Catheter Gauge: 5 French
• Catheter Working Length: 65 Centimeter
• Catheter Inner Diameter: 0.048 Inch
• Catheter Gauge: 5 French
• Catheter Working Length: 65 Centimeter
• Catheter Inner Diameter: 0.048 Inch
• Catheter Gauge: 5 French
• Catheter Working Length: 65 Centimeter
• Catheter Inner Diameter: 0.048 Inch
• Catheter Gauge: 5 French
• Catheter Working Length: 65 Centimeter
• Catheter Inner Diameter: 0.048 Inch
• Catheter Gauge: 5 French
• Catheter Working Length: 65 Centimeter
• Catheter Inner Diameter: 0.048 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857136004255 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233858

FDA Product Code

• DQY: Catheter, Percutaneous

Sterilization

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

[00857136004255]

Ethylene Oxide

[00857136004255]

Ethylene Oxide

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[00857136004255]

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[00857136004255]

Ethylene Oxide

[00857136004255]

Ethylene Oxide

[00857136004255]

Ethylene Oxide

[00857136004255]

Ethylene Oxide

[00857136004255]

Ethylene Oxide

[00857136004255]

Ethylene Oxide

[00857136004255]

Ethylene Oxide

[00857136004255]

Ethylene Oxide

[00857136004255]

Ethylene Oxide

[00857136004255]

Ethylene Oxide

[00857136004255]

Ethylene Oxide

[00857136004255]

Ethylene Oxide

[00857136004255]

Ethylene Oxide

[00857136004255]

Ethylene Oxide

[00857136004255]

Ethylene Oxide

[00857136004255]

Ethylene Oxide

[00857136004255]

Ethylene Oxide

[00857136004255]

Ethylene Oxide

[00857136004255]

Ethylene Oxide

[00857136004255]

Ethylene Oxide

[00857136004255]

Ethylene Oxide

[00857136004255]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-08-19
• Device Publish Date: 2024-08-09

On-Brand Devices [TriGuide Guiding Catheter]

• 00857136004262: TriSalus TriGuide Guiding Catheter, 5F, Cobra Shape, 0.048" ID, 65cm Usable Length
• 00857136004255: TriSalus TriGuide Guiding Catheter, 5F, Simmons 1 (SIM1) Shape, 0.048" ID, 65cm Usable Length
• 00857136004248: TriSalus TriGuide Guiding Catheter, 5F, Axis Shape, 0.048" ID, 65cm Usable Length