Omeza®

GUDID 00859839007212

Omeza, LLC

Collagen wound matrix dressing

• Primary Device ID: 00859839007212
• NIH Device Record Key: fe254fa2-1cd7-437e-9b86-b699382143c2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Omeza®
• Version Model Number: CM-720.001
• Company DUNS: 057694073
• Company Name: Omeza, LLC
• 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: 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	00859839007014 [Primary]
GS1	00859839007038 [Package]; Contains: 00859839007014; Package: Carton [4 Units]; In Commercial Distribution
GS1	00859839007212 [Package]; Contains: 00859839007014; Package: Box CM-720.010 [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211972

FDA Product Code

• FRO: Dressing, Wound, Drug

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: 2021-11-15
• Device Publish Date: 2021-11-05

On-Brand Devices [Omeza®]

• 00859839007205: CM-720.001
• 00859839007212: CM-720.001