ReSolve®, StayFIX® RBDC-10-SFX/A

GUDID 10884450057497

Merit Medical Systems, Inc.

Biliary drainage catheter

• Primary Device ID: 10884450057497
• NIH Device Record Key: 3c370130-8b41-449c-8b98-4893b077cd65
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ReSolve®, StayFIX®
• Version Model Number: 00884450057490
• Catalog Number: RBDC-10-SFX/A
• 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: true
• 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: false
• OTC Over-The-Counter: false

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Device Identifiers

Device Issuing Agency	Device ID
GS1	00884450057490 [Primary]
GS1	10884450057497 [Package]; Contains: 00884450057490; Package: [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141408

FDA Product Code

• FGE: Stents, drains and dilators for the biliary ducts

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-03-01

On-Brand Devices [ReSolve®, StayFIX®]

• 10884450071516: 00884450071519
• 10884450071509: 00884450071502
• 10884450057848: 00884450057841
• 10884450057558: 00884450057551
• 10884450057527: 00884450057520
• 10884450057497: 00884450057490
• 10884450057466: 00884450057469
• 10884450057459: 00884450057452
• 10884450028657: 00884450028650
• 10884450028640: 00884450028643
• 10884450028633: 00884450028636
• 10884450028619: 00884450028612
• 10884450026103: 00884450026106
• 10884450022266: 00884450022269
• 10884450022259: 00884450022252
• 10884450022242: 00884450022245
• 10884450726966: 00884450726969
• 10884450731601: 00884450731604
• 10884450726942: 00884450726945