Flagship HS 1812-001-011

GUDID 10816349010986

BRIVANT LIMITED

Cardiac/peripheral vascular guidewire, single-use

• Primary Device ID: 10816349010986
• NIH Device Record Key: 10d3a9cb-0d8d-4f3f-b03e-17dec39fe858
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Flagship HS
• Version Model Number: FSHP HS-6,NOR,J,HY,RDG 195-014
• Catalog Number: 1812-001-011
• Company DUNS: 985303473
• Company Name: BRIVANT LIMITED
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816349010989 [Primary]
GS1	10816349010986 [Package]; Contains: 00816349010989; Package: Inner Carton [5 Units]; In Commercial Distribution

FDA Product Code

• DQX: Wire, Guide, Catheter

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-05-05

On-Brand Devices [Flagship HS ]

• 10816349010993: FSHP HS-9,NOR,S,HY,RDG 195-014
• 10816349010986: FSHP HS-6,NOR,J,HY,RDG 195-014
• 10816349010979: FSHP HS-3,NOR,S,HY,RDG 195-014
• 10816349010962: FSHP HS-12,S,HY,RDG/WDG195-014
• 10816349010955: FSHP HS-9,S,HY,RDG,WDG 195-014