SteadySheath® LR-TSS-11.0

GUDID 10884450441777

Merit Medical Systems, Inc.

Fascial tissue dilator, single-use

• Primary Device ID: 10884450441777
• NIH Device Record Key: 567c1613-06de-432c-8c74-a56529d42c45
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SteadySheath®
• Version Model Number: B
• Catalog Number: LR-TSS-11.0
• 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	00884450441770 [Primary]
GS1	10884450441777 [Package]; Contains: 00884450441770; Package: [44 Units]; In Commercial Distribution

FDA Product Code

• DRE: DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

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: 2026-03-16
• Device Publish Date: 2026-03-06

On-Brand Devices [SteadySheath®]

• 10884450441791: B
• 10884450441777: B