VASSALLO GT EXT VGT14165EXT

GUDID 14582105830117

FILMEC K.K.

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