Merit S-MAK™ S-MAK5F-10/A

GUDID 10884450013288

Merit Medical Systems, Inc.

Vascular dilator, single-use

• Primary Device ID: 10884450013288
• NIH Device Record Key: b6fe746e-d8e9-46f7-8118-57bc85d6f39c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Merit S-MAK™
• Version Model Number: 00884450013281
• Catalog Number: S-MAK5F-10/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	00884450013281 [Primary]
GS1	10884450013288 [Package]; Contains: 00884450013281; Package: [5 Units]; In Commercial Distribution
GS1	20884450013285 [Package]; Package: [15 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K031691

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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

On-Brand Devices [Merit S-MAK™]

• 10884450155070: 00884450155073
• 10884450155063: 00884450155066
• 10884450155049: 00884450155042
• 10884450144463: 00884450144466
• 10884450144456: 00884450144459
• 10884450144449: 00884450144442
• 10884450144432: 00884450144435
• 10884450013295: 00884450013298
• 10884450013288: 00884450013281
• 10884450013271: 00884450013274
• 10884450012861: 00884450012864
• 10884450012663: 00884450012666
• 10884450012656: 00884450012659
• 10884450012649: 00884450012642
• 10884450012632: 00884450012635
• 10884450012625: 00884450012628
• 10884450012618: 00884450012611
• 10884450410438: 00884450410431
• 10884450847357: C
• 10884450860356: T
• 10884450847340: F