F-18 Flex

GUDID 14582233916325

Guidewire

FMD CO., LTD.

Cardiac/peripheral vascular guidewire, single-use

• Primary Device ID: 14582233916325
• NIH Device Record Key: 9ace0dea-3d2e-4392-bc51-b300d813c7e4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: F-18 Flex
• Version Model Number: F18F04ST235
• Company DUNS: 696947837
• Company Name: FMD CO., LTD.
• 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 Dimensions

• Length: 235 Centimeter
• Outer Diameter: 0.018 Inch
• Length: 235 Centimeter
• Outer Diameter: 0.018 Inch
• Length: 235 Centimeter
• Outer Diameter: 0.018 Inch
• Length: 235 Centimeter
• Outer Diameter: 0.018 Inch
• Length: 235 Centimeter
• Outer Diameter: 0.018 Inch
• Length: 235 Centimeter
• Outer Diameter: 0.018 Inch
• Length: 235 Centimeter
• Outer Diameter: 0.018 Inch
• Length: 235 Centimeter
• Outer Diameter: 0.018 Inch
• Length: 235 Centimeter
• Outer Diameter: 0.018 Inch
• Length: 235 Centimeter
• Outer Diameter: 0.018 Inch
• Length: 235 Centimeter
• Outer Diameter: 0.018 Inch
• Length: 235 Centimeter
• Outer Diameter: 0.018 Inch
• Length: 235 Centimeter
• Outer Diameter: 0.018 Inch
• Length: 235 Centimeter
• Outer Diameter: 0.018 Inch
• Length: 235 Centimeter
• Outer Diameter: 0.018 Inch
• Length: 235 Centimeter
• Outer Diameter: 0.018 Inch
• Length: 235 Centimeter
• Outer Diameter: 0.018 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	04582233916328 [Primary]
GS1	14582233916325 [Package]; Contains: 04582233916328; Package: [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212268

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: 2024-08-28
• Device Publish Date: 2024-08-20

On-Brand Devices [F-18 Flex]

• 14582233916332: Guidewire
• 14582233916387: Guidewire
• 14582233916325: Guidewire
• 14582233916318: Guidewire