Coaxial Introducer PP1915/B

GUDID 20884450443181

Merit Medical Systems, Inc.

Soft-tissue biopsy procedure kit, non-medicated Soft-tissue biopsy procedure kit, non-medicated Soft-tissue biopsy procedure kit, non-medicated Soft-tissue biopsy procedure kit, non-medicated Soft-tissue biopsy procedure kit, non-medicated Soft-tissue biopsy procedure kit, non-medicated Soft-tissue biopsy procedure kit, non-medicated Soft-tissue biopsy procedure kit, non-medicated Soft-tissue biopsy procedure kit, non-medicated Soft-tissue biopsy procedure kit, non-medicated Soft-tissue biopsy procedure kit, non-medicated Soft-tissue biopsy procedure kit, non-medicated Soft-tissue biopsy procedure kit, non-medicated Soft-tissue biopsy procedure kit, non-medicated Soft-tissue biopsy procedure kit, non-medicated Soft-tissue biopsy procedure kit, non-medicated

• Primary Device ID: 20884450443181
• NIH Device Record Key: 0175ef68-34a7-419d-8b74-a181479c149d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Coaxial Introducer
• Version Model Number: 10884450443184
• Catalog Number: PP1915/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: 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

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Device Identifiers

Device Issuing Agency	Device ID
GS1	00884450443187 [Unit of Use]
GS1	10884450443184 [Primary]
GS1	20884450443181 [Package]; Contains: 10884450443184; 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: 2023-05-22
• Device Publish Date: 2023-05-12

On-Brand Devices [Coaxial Introducer]

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