EZGEL

GUDID D20230815

CosmoFrance

Blood collection set, invasive

• Primary Device ID: D20230815
• NIH Device Record Key: 8ce406a6-9b66-44f5-aec0-4efb6eb9c414
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EZGEL
• Version Model Number: EZ2K
• Company DUNS: 015144539
• Company Name: CosmoFrance
• 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: true
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D20230815 [Unit of Use]
HIBCC	G589EZGEL1 [Primary]

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: 2024-03-04
• Device Publish Date: 2024-02-23

Devices Manufactured by CosmoFrance

• G58927G04EZINJECT1 - EZINJECT: 2024-03-05
• G589EZ2K2 - EZPRF: 2024-03-04
• D20230209 - EZPRF: 2024-03-04
• D20230815 - EZGEL: 2024-03-04
• D20230815 - EZGEL: 2024-03-04
• 10652927727569 - Dermasculpt: 2024-01-31
• 10652927727620 - Dermasculpt: 2024-01-31
• 10652927727637 - Dermasculpt: 2024-01-31
• 10652927727644 - Dermasculpt: 2024-01-31