Bonalive Orthopedics granules 14130

GUDID 06438132141300

Synthetic bone substitute for regenerating bone

BonAlive Biomaterials Oy

Bone matrix implant, synthetic, non-antimicrobial
Primary Device ID06438132141300
NIH Device Record Key2dc50213-147c-4125-9d7f-602c8cb6d0cc
Commercial Distribution StatusIn Commercial Distribution
Brand NameBonalive Orthopedics granules
Version Model Number14130
Catalog Number14130
Company DUNS367881400
Company NameBonAlive Biomaterials Oy
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
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+358401774400
Emailcontact@bonalive.com
Phone+358401774400
Emailcontact@bonalive.com
Phone+358401774400
Emailcontact@bonalive.com
Phone+358401774400
Emailcontact@bonalive.com
Phone+358401774400
Emailcontact@bonalive.com
Phone+358401774400
Emailcontact@bonalive.com
Phone+358401774400
Emailcontact@bonalive.com
Phone+358401774400
Emailcontact@bonalive.com
Phone+358401774400
Emailcontact@bonalive.com
Phone+358401774400
Emailcontact@bonalive.com
Phone+358401774400
Emailcontact@bonalive.com
Phone+358401774400
Emailcontact@bonalive.com
Phone+358401774400
Emailcontact@bonalive.com
Phone+358401774400
Emailcontact@bonalive.com
Phone+358401774400
Emailcontact@bonalive.com
Phone+358401774400
Emailcontact@bonalive.com
Phone+358401774400
Emailcontact@bonalive.com
Phone+358401774400
Emailcontact@bonalive.com
Phone+358401774400
Emailcontact@bonalive.com
Phone+358401774400
Emailcontact@bonalive.com
Phone+358401774400
Emailcontact@bonalive.com
Phone+358401774400
Emailcontact@bonalive.com
Phone+358401774400
Emailcontact@bonalive.com
Phone+358401774400
Emailcontact@bonalive.com
Phone+358401774400
Emailcontact@bonalive.com
Phone+358401774400
Emailcontact@bonalive.com
Phone+358401774400
Emailcontact@bonalive.com
Phone+358401774400
Emailcontact@bonalive.com
Phone+358401774400
Emailcontact@bonalive.com
Phone+358401774400
Emailcontact@bonalive.com

Device Dimensions

Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter
Total Volume5 Milliliter

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS106438132141300 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-09-08
Device Publish Date2020-08-31

On-Brand Devices [Bonalive Orthopedics granules]

06438132143403Synthetic bone substitute for regenerating bone
06438132143304Synthetic bone substitute for regenerating bone
06438132141409Synthetic bone substitute for regenerating bone
06438132141300Synthetic bone substitute for regenerating bone
06438132141201Synthetic bone substitute for regenerating bone
06438132141102Synthetic bone substitute for regenerating bone

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