ALIMAXX-ES™ 80129-205/C

GUDID 10884450030674

Merit Medical Systems, Inc.

Polymer-metal oesophageal stent, non-sterile

• Primary Device ID: 10884450030674
• NIH Device Record Key: e2d33e04-2aee-43b1-af5a-9b87c957c92f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ALIMAXX-ES™
• Version Model Number: 00884450030677
• Catalog Number: 80129-205/C
• Company DUNS: 184763290
• Company Name: Merit Medical Systems, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• 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: false
• OTC Over-The-Counter: false

Device Dimensions

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Device Identifiers

Device Issuing Agency	Device ID
GS1	00884450030677 [Primary]
GS1	10884450030674 [Package]; Contains: 00884450030677; Package: [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080838

FDA Product Code

• ESW: PROSTHESIS, ESOPHAGEAL

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-10-31

On-Brand Devices [ALIMAXX-ES™]

• 10884450038595: 00884450038598
• 10884450038588: 00884450038581
• 10884450038571: 00884450038574
• 10884450038564: 00884450038567
• 10884450038557: 00884450038550
• 10884450038540: 00884450038543
• 10884450033521: 00884450033524
• 10884450033514: 00884450033517
• 10884450033507: 00884450033500
• 10884450030681: 00884450030684
• 10884450030674: 00884450030677
• 10884450030667: 00884450030660
• 10884450030650: 00884450030653
• 10884450030643: 00884450030646
• 10884450030636: 00884450030639
• 00884450694138: F
• 00884450694121: F
• 00884450694114: F
• 00884450694107: F
• 00884450694091: F
• 00884450694084: F
• 00884450694077: F
• 00884450694060: F
• 00884450694053: F
• 00884450494844: D
• 00884450494806: D
• 00884450494745: D