Worley Advanced CSG WOR-CSG-B1-09/A

GUDID 10884450484316

Merit Medical Systems, Inc.

Vascular catheter introduction set, nonimplantable

• Primary Device ID: 10884450484316
• NIH Device Record Key: 7b6a8334-712d-40ef-9601-8e52202d4e40
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Worley Advanced CSG
• Version Model Number: 00884450484319
• Catalog Number: WOR-CSG-B1-09/A
• Company DUNS: 184763290
• Company Name: Merit Medical Systems, 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: 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	00884450484319 [Primary]
GS1	10884450484316 [Package]; Contains: 00884450484319; 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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-07-31
• Device Publish Date: 2020-07-23

On-Brand Devices [Worley Advanced CSG]

• 10884450484484: 00884450484487
• 10884450484460: 00884450484463
• 10884450484453: 00884450484456
• 10884450484316: 00884450484319
• 10884450484477: 00884450484470