SteadySheath® LR-TSS-13.0

GUDID 10884450441784

Merit Medical Systems, Inc.

Fascial tissue dilator, single-use

• Primary Device ID: 10884450441784
• NIH Device Record Key: 77fb7002-21a6-4598-8d8b-e668b2a24bf6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SteadySheath®
• Version Model Number: B
• Catalog Number: LR-TSS-13.0
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00884450441787 [Primary]
GS1	10884450441784 [Package]; Contains: 00884450441787; 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: 2026-03-30
• Device Publish Date: 2026-03-21

On-Brand Devices [SteadySheath®]

• 10884450441791: B
• 10884450441777: B
• 10884450441784: B