Flagship 1601-010-011

GUDID 10816349010917

BRIVANT LIMITED

Cardiac/peripheral vascular guidewire, single-use

• Primary Device ID: 10816349010917
• NIH Device Record Key: 206f66e6-6203-401e-88c9-3d6d467b9dd9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Flagship
• Version Model Number: FSHP, FLPY, NOR, S, HY 300-014
• Catalog Number: 1601-010-011
• 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	00816349010910 [Primary]
GS1	10816349010917 [Package]; Contains: 00816349010910; 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: 2017-04-21

On-Brand Devices [Flagship ]

• 10816349010917: FSHP, FLPY, NOR, S, HY 300-014
• 00816349010903: FSHP STD, NOR, J, HY, 195-014
• 00816349010897: FSHP MED, NOR, S, HY 195-014
• 10816349010887: FSHP FLPY, XSUP, S, HY 195-014
• 00816349010873: FSHP, FLPY, NOR, S, HY 195-014
• 10816349012348: 1603-000-011