Coaxial Introducer PP1715/B

GUDID 20884450443143

Merit Medical Systems, Inc.

Soft-tissue biopsy procedure kit, non-medicated

• Primary Device ID: 20884450443143
• NIH Device Record Key: 9d15ef34-0077-431a-9d76-e9cbaaa316c9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Coaxial Introducer
• Version Model Number: 10884450443146
• Catalog Number: PP1715/B
• Company DUNS: 184763290
• Company Name: Merit Medical Systems, Inc.
• Device Count: 10
• DM Exempt: false
• Pre-market Exempt: true
• 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	00884450443149 [Unit of Use]
GS1	10884450443146 [Primary]
GS1	20884450443143 [Package]; Contains: 10884450443146; Package: [18 Units]; In Commercial Distribution

FDA Product Code

• GDF: GUIDE, NEEDLE, SURGICAL

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: 2021-05-11
• Device Publish Date: 2021-05-03

On-Brand Devices [Coaxial Introducer]

• 20884450443143: 10884450443146
• 20884450443105: 10884450443108
• 20884450443082: 10884450443085
• 20884450443150: 10884450443153
• 20884450443099: 10884450443092
• 20884450443204: 10884450443207
• 20884450443228: 10884450443221
• 20884450443181: 10884450443184