Sinutwist 901059-05

GUDID 00816349011665

BRIVANT LIMITED

Cardiac/peripheral vascular guidewire, single-use

• Primary Device ID: 00816349011665
• NIH Device Record Key: 15382e5d-16c5-4d8e-a1b9-265e186d69c6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sinutwist
• Version Model Number: SINUTWIST GW, DS-J, J 190-014
• Catalog Number: 901059-05
• 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	00816349011665 [Primary]

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: 2018-04-02
• Device Publish Date: 2018-02-28

On-Brand Devices [Sinutwist]

• 00816349011672: SINUTWIST GW, EDS-J, J 190-014
• 00816349011665: SINUTWIST GW, DS-J, J 190-014
• 00816349011658: SINUTWIST GW, ES-J, J 190-014
• 00816349011641: SINUTWIST GW, EDS, S 190-014
• 00816349011634: SINUTWIST GW, DS, S 190-014
• 00816349011627: SINUTWIST GW, ES, S 190-014