Allogran-R® 800-010

GUDID 50601557100370

Allogran-R® Tri-Calcium Phosphate Bone Graft Substitute is provided sterile for single patient use. The biodegradable, radiopaque granules/blocks are

BIOCOMPOSITES LTD

Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft

• Primary Device ID: 50601557100370
• NIH Device Record Key: 9d8cd028-18ae-478c-a4e4-f6a3490794cb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Allogran-R®
• Version Model Number: 800-010
• Catalog Number: 800-010
• Company DUNS: 424382307
• Company Name: BIOCOMPOSITES 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

Customer Support Contacts

• Phone: +441782338580
• Email: info@biocomposites.com
• Phone: +441782338580
• Email: info@biocomposites.com
• Phone: +441782338580
• Email: info@biocomposites.com
• Phone: +441782338580
• Email: info@biocomposites.com
• Phone: +441782338580
• Email: info@biocomposites.com
• Phone: +441782338580
• Email: info@biocomposites.com
• Phone: +441782338580
• Email: info@biocomposites.com
• Phone: +441782338580
• Email: info@biocomposites.com
• Phone: +441782338580
• Email: info@biocomposites.com
• Phone: +441782338580
• Email: info@biocomposites.com
• Phone: +441782338580
• Email: info@biocomposites.com
• Phone: +441782338580
• Email: info@biocomposites.com
• Phone: +441782338580
• Email: info@biocomposites.com
• Phone: +441782338580
• Email: info@biocomposites.com
• Phone: +441782338580
• Email: info@biocomposites.com
• Phone: +441782338580
• Email: info@biocomposites.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 45 Degrees Celsius
• Storage Environment Temperature: Between 39 Degrees Fahrenheit and 113 Degrees Fahrenheit
• Storage Environment Temperature: Between 4 Degrees Celsius and 45 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	50601557100370 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061311

FDA Product Code

• MQV: Filler, Bone Void, Calcium Compound

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: 2015-04-01

On-Brand Devices [Allogran-R®]

• 50601557100448: Allogran-R® Tri-Calcium Phosphate Bone Graft Substitute is provided sterile for single patient
• 50601557100370: Allogran-R® Tri-Calcium Phosphate Bone Graft Substitute is provided sterile for single patient
• 50601557100202: Allogran-R® Tri-Calcium Phosphate Bone Graft Substitute is provided sterile for single patient