Worley Advanced CSG WOR-CSG-B1-09

GUDID 10884450169459

Merit Medical

Vascular catheter introduction set, nonimplantable

• Primary Device ID: 10884450169459
• NIH Device Record Key: bed99338-29fc-44c8-aba0-6b3f3414ff86
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Worley Advanced CSG
• Version Model Number: 00884450169452
• Catalog Number: WOR-CSG-B1-09
• Company DUNS: 065673912
• Company Name: Merit Medical
• 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: true
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884450169452 [Primary]
GS1	10884450169459 [Package]; Contains: 00884450169452; Package: [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120158

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: 4
• Public Version Date: 2019-06-07
• Device Publish Date: 2017-02-15

On-Brand Devices [Worley Advanced CSG]

• 10884450271039: 00884450271032
• 10884450241308: 00884450241301
• 10884450169473: 00884450169476
• 10884450169466: 00884450169469
• 10884450169459: 00884450169452