Allogran-R® 800-020

GUDID 50601557100448

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

• Primary Device ID: 50601557100448
• NIH Device Record Key: 79aa46b8-6ae2-4b64-a21a-99b35babf50a
• Commercial Distribution Discontinuation: 2015-12-31
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Allogran-R®
• Version Model Number: 800-020
• Catalog Number: 800-020
• 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

Device Dimensions

• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	50601557100448 [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