OSSIX® PLUS

GUDID 07290015477727

Resorbable collagen membrane

DATUM DENTAL LTD

Collagen dental regeneration membrane Collagen dental regeneration membrane Collagen dental regeneration membrane Collagen dental regeneration membrane Collagen dental regeneration membrane Collagen dental regeneration membrane Collagen dental regeneration membrane Collagen dental regeneration membrane Collagen dental regeneration membrane Collagen dental regeneration membrane Collagen dental regeneration membrane Collagen dental regeneration membrane Collagen dental regeneration membrane Collagen dental regeneration membrane Collagen dental regeneration membrane Collagen dental regeneration membrane

• Primary Device ID: 07290015477727
• NIH Device Record Key: 42944996-4d49-4f08-84d4-9a165f7305af
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OSSIX® PLUS
• Version Model Number: OXP2530
• 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

• Length: 30 Millimeter
• Width: 25 Millimeter
• Length: 30 Millimeter
• Width: 25 Millimeter
• Length: 30 Millimeter
• Width: 25 Millimeter
• Length: 30 Millimeter
• Width: 25 Millimeter
• Length: 30 Millimeter
• Width: 25 Millimeter
• Length: 30 Millimeter
• Width: 25 Millimeter
• Length: 30 Millimeter
• Width: 25 Millimeter
• Length: 30 Millimeter
• Width: 25 Millimeter
• Length: 30 Millimeter
• Width: 25 Millimeter
• Length: 30 Millimeter
• Width: 25 Millimeter
• Length: 30 Millimeter
• Width: 25 Millimeter
• Length: 30 Millimeter
• Width: 25 Millimeter
• Length: 30 Millimeter
• Width: 25 Millimeter
• Length: 30 Millimeter
• Width: 25 Millimeter
• Length: 30 Millimeter
• Width: 25 Millimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290015477727 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K053260

FDA Product Code

• NPL: Barrier, Animal Source, Intraoral

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-09-27

On-Brand Devices [OSSIX® PLUS]

• 07290015477765: Resorbable collagen membrane
• 07290015477727: Resorbable collagen membrane
• 07290015477710: Resorbable collagen membrane