EsophyX® Z+ R2007

GUDID 00884450848111

Merit Medical Systems, Inc.

Gastro-oesophageal antireflux fundal implant placement tool, single-use

• Primary Device ID: 00884450848111
• NIH Device Record Key: 7feec05b-5a91-446a-899a-afb29460714a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EsophyX® Z+
• Version Model Number: A
• Catalog Number: R2007
• Company DUNS: 184763290
• Company Name: Merit Medical Systems, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00884450848111 [Primary]

FDA Product Code

• ODE: Endoscopic suture/plication system, gastroesophageal reflux disease (gerd)

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: 2026-01-22
• Device Publish Date: 2026-01-14

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