RESILIENCE™ RE145

GUDID 00884450093580

Merit Medical Systems, Inc.

Polymer-metal oesophageal stent

• Primary Device ID: 00884450093580
• NIH Device Record Key: bbf561df-c45a-48be-9d30-d731744579a5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RESILIENCE™
• Version Model Number: A
• Catalog Number: RE145
• 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: 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 Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00884450093580 [Primary]
GS1	10884450093587 [Package]; Package: [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K251265

FDA Product Code

• ESW: PROSTHESIS, ESOPHAGEAL

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: 2026-02-02
• Device Publish Date: 2026-01-24

On-Brand Devices [RESILIENCE™]

• 00884450094242: A
• 00884450094105: A
• 00884450094037: A
• 00884450094020: A
• 00884450093917: A
• 00884450093627: A
• 00884450093603: A
• 00884450093597: A
• 00884450093580: A