Eleview

GUDID 05391530190053

2 Ampoules, 10 mL each. To facilitate endoscopic resection procedures. For sample use only, not for resale.

COSMO TECHNOLOGIES LIMITED

Submucosal lift solution/gel Submucosal lift solution/gel Submucosal lift solution/gel Submucosal lift solution/gel Submucosal lift solution/gel Submucosal lift solution/gel Submucosal lift solution/gel Submucosal lift solution/gel Submucosal lift solution/gel Submucosal lift solution/gel Submucosal lift solution/gel Submucosal lift solution/gel Submucosal lift solution/gel Submucosal lift solution/gel

• Primary Device ID: 05391530190053
• NIH Device Record Key: e7de8094-d3a0-46c7-a5d1-c47c5cb24261
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Eleview
• Version Model Number: 9000008
• Company DUNS: 989891457
• Company Name: COSMO TECHNOLOGIES LIMITED
• Device Count: 2
• 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05391530190053 [Primary]
GS1	05391530190312 [Unit of Use]

FDA Product Code

• PLL: Submucosal Injection Agent

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-05-03
• Device Publish Date: 2019-12-19

On-Brand Devices [Eleview]

• 05391530190015: A sterile solution intended to be injected via an endoscopic injection needle into the submucosa
• 05391530190008: 5 Ampoules, 10 mL each. To facilitate endoscopic resection procedures.
• 05391530190053: 2 Ampoules, 10 mL each. To facilitate endoscopic resection procedures. For sample use only, not