OSSIX® Breeze

GUDID 07290015477314

Cross-linked pericardium membrane

DATUM DENTAL LTD

Collagen dental regeneration membrane

• Primary Device ID: 07290015477314
• NIH Device Record Key: 3a897c6f-4a70-42e4-a86d-0bebf7461808
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OSSIX® Breeze
• Version Model Number: 68018005
• Company DUNS: 600170232
• Company Name: DATUM DENTAL LTD
• 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 Dimensions

• Width: 15 Millimeter
• Length: 20 Millimeter
• Width: 15 Millimeter
• Length: 20 Millimeter
• Width: 15 Millimeter
• Length: 20 Millimeter
• Width: 15 Millimeter
• Length: 20 Millimeter
• Width: 15 Millimeter
• Length: 20 Millimeter
• Width: 15 Millimeter
• Length: 20 Millimeter
• Width: 15 Millimeter
• Length: 20 Millimeter
• Width: 15 Millimeter
• Length: 20 Millimeter
• Width: 15 Millimeter
• Length: 20 Millimeter
• Width: 15 Millimeter
• Length: 20 Millimeter
• Width: 15 Millimeter
• Length: 20 Millimeter
• Width: 15 Millimeter
• Length: 20 Millimeter
• Width: 15 Millimeter
• Length: 20 Millimeter
• Width: 15 Millimeter
• Length: 20 Millimeter
• Width: 15 Millimeter
• Length: 20 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290015477314 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212509

FDA Product Code

• NPL: Barrier, Animal Source, Intraoral

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: 2022-09-13
• Device Publish Date: 2022-09-05

On-Brand Devices [OSSIX® Breeze]

• 07290015477338: Cross-linked pericardium membrane
• 07290015477321: Cross-linked pericardium membrane
• 07290015477314: Cross-linked pericardium membrane
• 07290015477307: Cross-linked pericardium membrane