OSSIX® PLUS

GUDID 07290015477710

Resorbable collagen membrane

DATUM DENTAL LTD

Collagen dental regeneration membrane

• Primary Device ID: 07290015477710
• NIH Device Record Key: 7a1d662f-43ab-49ef-aa20-034c40c49865
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OSSIX® PLUS
• Version Model Number: OXP3040
• 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: 40 Millimeter
• Width: 30 Millimeter
• Length: 40 Millimeter
• Width: 30 Millimeter
• Length: 40 Millimeter
• Width: 30 Millimeter
• Length: 40 Millimeter
• Width: 30 Millimeter
• Length: 40 Millimeter
• Width: 30 Millimeter
• Length: 40 Millimeter
• Width: 30 Millimeter
• Length: 40 Millimeter
• Width: 30 Millimeter
• Length: 40 Millimeter
• Width: 30 Millimeter
• Length: 40 Millimeter
• Width: 30 Millimeter
• Length: 40 Millimeter
• Width: 30 Millimeter
• Length: 40 Millimeter
• Width: 30 Millimeter
• Length: 40 Millimeter
• Width: 30 Millimeter
• Length: 40 Millimeter
• Width: 30 Millimeter
• Length: 40 Millimeter
• Width: 30 Millimeter
• Length: 40 Millimeter
• Width: 30 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	07290015477710 [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