EndoMAXX® MAXX-197/C

GUDID 10884450093105

Merit Medical Systems, Inc.

Polymer-metal oesophageal stent, non-sterile

• Primary Device ID: 10884450093105
• NIH Device Record Key: a764a71c-00d2-4ffa-aafa-5835e84c63b4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EndoMAXX®
• Version Model Number: 00884450093108
• Catalog Number: MAXX-197/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	00884450093108 [Primary]
GS1	10884450093105 [Package]; Contains: 00884450093108; Package: [1 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111611

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 [EndoMAXX®]

• 10884450147648: 00884450147641
• 10884450147631: 00884450147634
• 10884450147624: 00884450147627
• 10884450147617: 00884450147610
• 10884450093105: 00884450093108
• 10884450093082: 00884450093085
• 10884450093068: 00884450093061
• 10884450093044: 00884450093047
• 10884450442354: 00884450442357
• 10884450442316: 00884450442319
• 10884450442330: 00884450442333
• 10884450442231: 00884450442234
• 10884450442255: 00884450442258
• 10884450442378: 00884450442371
• 10884450442293: 00884450442296
• 10884450442279: 00884450442272
• 00884450610879: E
• 00884450610855: E
• 00884450610831: E
• 00884450610817: E
• 00884450610794: E
• 00884450610770: E
• 00884450610756: E
• 00884450610732: E