OSSIX Agile™

GUDID 07290015477345

Cross-linked pericardium membrane

DATUM DENTAL LTD

Collagen dental regeneration membrane

• Primary Device ID: 07290015477345
• NIH Device Record Key: a3ed8af8-ace5-4e5c-8555-9a73b5efb1a1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OSSIX Agile™
• Version Model Number: 68018004
• 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: 10 Millimeter
• Length: 12 Millimeter
• Width: 10 Millimeter
• Length: 12 Millimeter
• Width: 10 Millimeter
• Length: 12 Millimeter
• Width: 10 Millimeter
• Length: 12 Millimeter
• Width: 10 Millimeter
• Length: 12 Millimeter
• Width: 10 Millimeter
• Length: 12 Millimeter
• Width: 10 Millimeter
• Length: 12 Millimeter
• Width: 10 Millimeter
• Length: 12 Millimeter
• Width: 10 Millimeter
• Length: 12 Millimeter
• Width: 10 Millimeter
• Length: 12 Millimeter
• Width: 10 Millimeter
• Length: 12 Millimeter
• Width: 10 Millimeter
• Length: 12 Millimeter
• Width: 10 Millimeter
• Length: 12 Millimeter
• Width: 10 Millimeter
• Length: 12 Millimeter
• Width: 10 Millimeter
• Length: 12 Millimeter
• Width: 10 Millimeter
• Length: 12 Millimeter
• Width: 10 Millimeter
• Length: 12 Millimeter
• Width: 10 Millimeter
• Length: 12 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290015477345 [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: 2023-06-13
• Device Publish Date: 2023-06-05

On-Brand Devices [OSSIX Agile™]

• 07290015477376: Cross-linked pericardium membrane
• 07290015477369: Cross-linked pericardium membrane
• 07290015477352: Cross-linked pericardium membrane
• 07290015477345: Cross-linked pericardium membrane