VASSALLO GT EXT VGT14165EXT

GUDID 14582105830117

FILMEC K.K.

Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual Peripheral vascular guidewire, manual

• Primary Device ID: 14582105830117
• NIH Device Record Key: 56365ba7-6724-484e-bb91-d353c9194950
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VASSALLO GT EXT
• Version Model Number: VGT14165EXT
• Catalog Number: VGT14165EXT
• Company DUNS: 718142096
• Company Name: FILMEC K.K.
• 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: 165 Centimeter
• Outer Diameter: 0.014 Inch
• Length: 165 Centimeter
• Outer Diameter: 0.014 Inch
• Length: 165 Centimeter
• Outer Diameter: 0.014 Inch
• Length: 165 Centimeter
• Outer Diameter: 0.014 Inch
• Length: 165 Centimeter
• Outer Diameter: 0.014 Inch
• Length: 165 Centimeter
• Outer Diameter: 0.014 Inch
• Length: 165 Centimeter
• Outer Diameter: 0.014 Inch
• Length: 165 Centimeter
• Outer Diameter: 0.014 Inch
• Length: 165 Centimeter
• Outer Diameter: 0.014 Inch
• Length: 165 Centimeter
• Outer Diameter: 0.014 Inch
• Length: 165 Centimeter
• Outer Diameter: 0.014 Inch
• Length: 165 Centimeter
• Outer Diameter: 0.014 Inch
• Length: 165 Centimeter
• Outer Diameter: 0.014 Inch
• Length: 165 Centimeter
• Outer Diameter: 0.014 Inch
• Length: 165 Centimeter
• Outer Diameter: 0.014 Inch
• Length: 165 Centimeter
• Outer Diameter: 0.014 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	04582105830110 [Primary]
GS1	14582105830117 [Package]; Contains: 04582105830110; Package: [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222631

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: 2023-05-26
• Device Publish Date: 2023-05-18

Devices Manufactured by FILMEC K.K.

• 04582105830035 - VASSALLO GT Crossing14: 2023-12-08
• 04582105830059 - VASSALLO GT Crossing14: 2023-12-08
• 14582105830148 - VASSALLO GT Crossing12: 2023-12-08
• 14582105830155 - VASSALLO GT Crossing30: 2023-12-08
• 14582105830162 - VASSALLO GT Crossing12: 2023-12-08
• 14582105830179 - VASSALLO GT Crossing30: 2023-12-08
• 04582105830189 - VASSALLO GT 018 Hybrid: 2023-06-12
• 14582105830193 - VASSALLO GT 018 Hybrid: 2023-06-12