Surefire Guiding Catheter

GUDID 00857136004064

65cm. 5F Guiding Catheter with Sim1 Shape

SUREFIRE MEDICAL, INC.

Vascular guide-catheter, single-use

• Primary Device ID: 00857136004064
• NIH Device Record Key: 076022ec-9fc4-4f7f-ad98-bfc07a041dec
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Surefire Guiding Catheter
• Version Model Number: SGC-5065-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: false
• 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

• Length: 65 Centimeter
• Length: 65 Centimeter
• Length: 65 Centimeter
• Catheter Gauge: 5 French
• Lumen/Inner Diameter: 0.056 Inch
• Length: 65 Centimeter
• Catheter Gauge: 5 French
• Lumen/Inner Diameter: 0.056 Inch
• Length: 65 Centimeter
• Catheter Gauge: 5 French
• Lumen/Inner Diameter: 0.056 Inch
• Length: 65 Centimeter
• Catheter Gauge: 5 French
• Lumen/Inner Diameter: 0.056 Inch
• Length: 65 Centimeter
• Catheter Gauge: 5 French
• Lumen/Inner Diameter: 0.056 Inch
• Length: 65 Centimeter
• Catheter Gauge: 5 French
• Lumen/Inner Diameter: 0.056 Inch
• Length: 65 Centimeter
• Catheter Gauge: 5 French
• Lumen/Inner Diameter: 0.056 Inch
• Length: 65 Centimeter
• Catheter Gauge: 5 French
• Lumen/Inner Diameter: 0.056 Inch
• Length: 65 Centimeter
• Catheter Gauge: 5 French
• Lumen/Inner Diameter: 0.056 Inch
• Length: 65 Centimeter
• Catheter Gauge: 5 French
• Lumen/Inner Diameter: 0.056 Inch
• Length: 65 Centimeter
• Catheter Gauge: 5 French
• Lumen/Inner Diameter: 0.056 Inch
• Length: 65 Centimeter
• Catheter Gauge: 5 French
• Lumen/Inner Diameter: 0.056 Inch
• Length: 65 Centimeter
• Catheter Gauge: 5 French
• Lumen/Inner Diameter: 0.056 Inch
• Length: 65 Centimeter
• Catheter Gauge: 5 French
• Lumen/Inner Diameter: 0.056 Inch
• Length: 65 Centimeter
• Catheter Gauge: 5 French
• Lumen/Inner Diameter: 0.056 Inch
• Length: 65 Centimeter
• Catheter Gauge: 5 French
• Lumen/Inner Diameter: 0.056 Inch
• Length: 65 Centimeter
• Catheter Gauge: 5 French
• Lumen/Inner Diameter: 0.056 Inch
• Length: 65 Centimeter
• Catheter Gauge: 5 French
• Lumen/Inner Diameter: 0.056 Inch
• Length: 65 Centimeter
• Catheter Gauge: 5 French
• Lumen/Inner Diameter: 0.056 Inch
• Length: 65 Centimeter
• Catheter Gauge: 5 French
• Lumen/Inner Diameter: 0.056 Inch
• Length: 65 Centimeter
• Catheter Gauge: 5 French
• Lumen/Inner Diameter: 0.056 Inch
• Length: 65 Centimeter
• Catheter Gauge: 5 French
• Lumen/Inner Diameter: 0.056 Inch
• Length: 65 Centimeter
• Catheter Gauge: 5 French
• Lumen/Inner Diameter: 0.056 Inch
• Length: 65 Centimeter
• Catheter Gauge: 5 French
• Lumen/Inner Diameter: 0.056 Inch
• Length: 65 Centimeter
• Catheter Gauge: 5 French
• Lumen/Inner Diameter: 0.056 Inch
• Length: 65 Centimeter
• Catheter Gauge: 5 French
• Lumen/Inner Diameter: 0.056 Inch
• Length: 65 Centimeter
• Catheter Gauge: 5 French
• Lumen/Inner Diameter: 0.056 Inch
• Length: 65 Centimeter
• Catheter Gauge: 5 French
• Lumen/Inner Diameter: 0.056 Inch
• Length: 65 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00857136004064 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140034

FDA Product Code

• DQY: Catheter, Percutaneous

Sterilization

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

[00857136004064]

Ethylene Oxide

[00857136004064]

Ethylene Oxide

[00857136004064]

Ethylene Oxide

[00857136004064]

Ethylene Oxide

[00857136004064]

Ethylene Oxide

[00857136004064]

Ethylene Oxide

[00857136004064]

Ethylene Oxide

[00857136004064]

Ethylene Oxide

[00857136004064]

Ethylene Oxide

[00857136004064]

Ethylene Oxide

[00857136004064]

Ethylene Oxide

[00857136004064]

Ethylene Oxide

[00857136004064]

Ethylene Oxide

[00857136004064]

Ethylene Oxide

[00857136004064]

Ethylene Oxide

[00857136004064]

Ethylene Oxide

[00857136004064]

Ethylene Oxide

[00857136004064]

Ethylene Oxide

[00857136004064]

Ethylene Oxide

[00857136004064]

Ethylene Oxide

[00857136004064]

Ethylene Oxide

[00857136004064]

Ethylene Oxide

[00857136004064]

Ethylene Oxide

[00857136004064]

Ethylene Oxide

[00857136004064]

Ethylene Oxide

[00857136004064]

Ethylene Oxide

[00857136004064]

Ethylene Oxide

[00857136004064]

Ethylene Oxide

[00857136004064]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-01-23
• Device Publish Date: 2016-09-08

On-Brand Devices [Surefire Guiding Catheter]

• 00857136004071: 65cm, 5F Guiding Catheter with Axis Shape
• 00857136004064: 65cm. 5F Guiding Catheter with Sim1 Shape
• 00857136004057: 65cm, 5F Guiding Catheter with Cobra1 Shape