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 ID50601557100448
NIH Device Record Key79aa46b8-6ae2-4b64-a21a-99b35babf50a
Commercial Distribution Discontinuation2015-12-31
Commercial Distribution StatusNot in Commercial Distribution
Brand NameAllogran-R®
Version Model Number800-020
Catalog Number800-020
Company DUNS424382307
Company NameBIOCOMPOSITES LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+441782338580
Emailinfo@biocomposites.com
Phone+441782338580
Emailinfo@biocomposites.com

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0

Operating and Storage Conditions

Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 45 Degrees Celsius
Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 113 Degrees Fahrenheit
Storage Environment TemperatureBetween 4 Degrees Celsius and 45 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS150601557100448 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MQVFiller, Bone Void, Calcium Compound

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-04-01

On-Brand Devices [Allogran-R®]

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

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