VASSALLO GT 018 Hybrid VGT18300HYB

GUDID 14582105830193

FILMEC K.K.

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• Primary Device ID: 14582105830193
• NIH Device Record Key: 139c47c1-7b10-4ee7-bd28-7cb890798ef4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VASSALLO GT 018 Hybrid
• Version Model Number: VGT18300HYB
• Catalog Number: VGT18300HYB
• 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: 300 Centimeter
• Outer Diameter: 0.018 Inch
• Length: 300 Centimeter
• Outer Diameter: 0.018 Inch
• Length: 300 Centimeter
• Outer Diameter: 0.018 Inch
• Length: 300 Centimeter
• Outer Diameter: 0.018 Inch
• Length: 300 Centimeter
• Outer Diameter: 0.018 Inch
• Length: 300 Centimeter
• Outer Diameter: 0.018 Inch
• Length: 300 Centimeter
• Outer Diameter: 0.018 Inch
• Length: 300 Centimeter
• Outer Diameter: 0.018 Inch
• Length: 300 Centimeter
• Outer Diameter: 0.018 Inch
• Length: 300 Centimeter
• Outer Diameter: 0.018 Inch
• Length: 300 Centimeter
• Outer Diameter: 0.018 Inch
• Length: 300 Centimeter
• Outer Diameter: 0.018 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	04582105830196 [Primary]
GS1	14582105830193 [Package]; Contains: 04582105830196; Package: [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K223432

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: 2023-06-12
• Device Publish Date: 2023-06-02

On-Brand Devices [VASSALLO GT 018 Hybrid]

• 14582105830193: VGT18300HYB
• 04582105830189: VGT18190HYB