EverLift GIS-55

GUDID 00893029002229

Submucosal Lifting Agent - 5mL Single Unit

GI Supply, Inc.

Submucosal lift solution

• Primary Device ID: 00893029002229
• NIH Device Record Key: 6c1966a9-38f0-437f-9088-4b97bbd7d9d0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EverLift
• Version Model Number: GIS-55
• Catalog Number: GIS-55
• Company DUNS: 160990313
• Company Name: GI Supply, 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: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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	00893029002229 [Primary]
GS1	10893029002226 [Package]; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191923

FDA Product Code

• PLL: Submucosal Injection Agent

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: 2021-02-26
• Device Publish Date: 2021-02-18

On-Brand Devices [EverLift]

• 10893029002240: Submucosal Lifting Agent - 10mL Single Unit
• 00893029002229: Submucosal Lifting Agent - 5mL Single Unit