VIZIGO D138502

GUDID 10846835016277

BIOSENSE WEBSTER INC.

Vascular catheter introduction set, nonimplantable

• Primary Device ID: 10846835016277
• NIH Device Record Key: 68f1369a-dce8-4e79-a0d5-f3a915bdcf90
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VIZIGO
• Version Model Number: D138502
• Catalog Number: D138502
• Company DUNS: 020163218
• Company Name: BIOSENSE WEBSTER INC.
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	10846835016277 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K170997

FDA Product Code

• DYB: INTRODUCER, 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: 3
• Public Version Date: 2019-06-07
• Device Publish Date: 2018-05-09

On-Brand Devices [VIZIGO]

• 10846835016277: D138502
• 10846835016260: D138503
• 10846835016253: D138501