Foundation® 27-500-100

GUDID 14560245656828

Collagen-Based Bone Filling Augmentation Material./ Product Overview: FOUNDATION is made of absorbable atelo-collagen. The atelo-collagen has been cro

OLYMPUS TERUMO BIOMATERIALS CORP.

Dental bone matrix implant, animal-derived

• Primary Device ID: 14560245656828
• NIH Device Record Key: 8cea1c11-bca4-4d82-947e-4a1e85892574
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Foundation®
• Version Model Number: 27-500-100
• Catalog Number: 27-500-100
• Company DUNS: 697730638
• Company Name: OLYMPUS TERUMO BIOMATERIALS CORP.
• 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

Customer Support Contacts

• Phone: 800-831-3222
• Email: info@jmoritausa.com
• Phone: 800-831-3222
• Email: info@jmoritausa.com
• Phone: 800-831-3222
• Email: info@jmoritausa.com
• Phone: 800-831-3222
• Email: info@jmoritausa.com
• Phone: 800-831-3222
• Email: info@jmoritausa.com
• Phone: 800-831-3222
• Email: info@jmoritausa.com
• Phone: 800-831-3222
• Email: info@jmoritausa.com
• Phone: 800-831-3222
• Email: info@jmoritausa.com
• Phone: 800-831-3222
• Email: info@jmoritausa.com
• Phone: 800-831-3222
• Email: info@jmoritausa.com
• Phone: 800-831-3222
• Email: info@jmoritausa.com
• Phone: 800-831-3222
• Email: info@jmoritausa.com
• Phone: 800-831-3222
• Email: info@jmoritausa.com
• Phone: 800-831-3222
• Email: info@jmoritausa.com

Device Dimensions

• Length: 25 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 25 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 25 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 25 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 25 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 25 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 25 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 25 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 25 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 25 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 25 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 25 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 25 Millimeter
• Outer Diameter: 8 Millimeter
• Length: 25 Millimeter
• Outer Diameter: 8 Millimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	04560245656821 [Primary]
GS1	14560245656828 [Package]; Contains: 04560245656821; Package: Box [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111087

FDA Product Code

• LYC: Bone Grafting Material, Synthetic

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: 2015-09-24

On-Brand Devices [Foundation®]

• 14560245656828: Collagen-Based Bone Filling Augmentation Material./ Product Overview: FOUNDATION is made of abso
• 14560245656811: Collagen-Based Bone Filling Augmentation Material./ Product Overview: FOUNDATION is made of abso