OSSIX™ Bone OXB0125

GUDID 07290015477215

OSSIX™ BONE is a biodegradable, osteoconductive, and biocompatible bone grafting material intended for guided tissue and bone regeneration. The OSSIX™

DATUM DENTAL LTD

Dental bone matrix implant, synthetic

• Primary Device ID: 07290015477215
• NIH Device Record Key: 076f15e3-2878-4e26-929e-a857cac08bbe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OSSIX™ Bone
• Version Model Number: 0.125 cc
• Catalog Number: OXB0125
• 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

• Device Size Text, specify: 0
• Depth: 5 Millimeter
• Length: 5 Millimeter
• Height: 5 Millimeter
• Device Size Text, specify: 0
• Depth: 5 Millimeter
• Length: 5 Millimeter
• Height: 5 Millimeter
• Device Size Text, specify: 0
• Depth: 5 Millimeter
• Length: 5 Millimeter
• Height: 5 Millimeter
• Device Size Text, specify: 0
• Depth: 5 Millimeter
• Length: 5 Millimeter
• Height: 5 Millimeter
• Device Size Text, specify: 0
• Depth: 5 Millimeter
• Length: 5 Millimeter
• Height: 5 Millimeter
• Device Size Text, specify: 0
• Depth: 5 Millimeter
• Length: 5 Millimeter
• Height: 5 Millimeter
• Device Size Text, specify: 0
• Depth: 5 Millimeter
• Length: 5 Millimeter
• Height: 5 Millimeter
• Device Size Text, specify: 0
• Depth: 5 Millimeter
• Length: 5 Millimeter
• Height: 5 Millimeter
• Device Size Text, specify: 0
• Depth: 5 Millimeter
• Length: 5 Millimeter
• Height: 5 Millimeter
• Device Size Text, specify: 0
• Depth: 5 Millimeter
• Length: 5 Millimeter
• Height: 5 Millimeter
• Device Size Text, specify: 0
• Depth: 5 Millimeter
• Length: 5 Millimeter
• Height: 5 Millimeter
• Device Size Text, specify: 0
• Depth: 5 Millimeter
• Length: 5 Millimeter
• Height: 5 Millimeter
• Device Size Text, specify: 0
• Depth: 5 Millimeter
• Length: 5 Millimeter
• Height: 5 Millimeter
• Device Size Text, specify: 0
• Depth: 5 Millimeter
• Length: 5 Millimeter
• Height: 5 Millimeter
• Device Size Text, specify: 0
• Depth: 5 Millimeter
• Length: 5 Millimeter
• Height: 5 Millimeter
• Device Size Text, specify: 0
• Depth: 5 Millimeter
• Length: 5 Millimeter
• Height: 5 Millimeter
• Device Size Text, specify: 0
• Depth: 5 Millimeter
• Length: 5 Millimeter
• Height: 5 Millimeter
• Device Size Text, specify: 0
• Depth: 5 Millimeter
• Length: 5 Millimeter
• Height: 5 Millimeter
• Device Size Text, specify: 0
• Depth: 5 Millimeter
• Length: 5 Millimeter
• Height: 5 Millimeter

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290015477215 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163714

FDA Product Code

• NPM: Bone Grafting Material, Animal Source

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: 2017-08-31

On-Brand Devices [OSSIX™ Bone]

• 07290015477253: OSSIX™ BONE is a biodegradable, osteoconductive, and biocompatible bone grafting material inte
• 07290015477222: OSSIX™ BONE is a biodegradable, osteoconductive, and biocompatible bone grafting material inte
• 07290015477215: OSSIX™ BONE is a biodegradable, osteoconductive, and biocompatible bone grafting material inte