MacroFORM Bioactive Packable Graft 5.0cc NB0399

GUDID 00813909010816

Synthetic bone void filler for orthopedic applications

NOVABONE PRODUCTS, LLC

Bone matrix implant, composite
Primary Device ID00813909010816
NIH Device Record Key4ef4afd2-fa87-412a-b380-464bda9e97bc
Commercial Distribution StatusIn Commercial Distribution
Brand NameMacroFORM Bioactive Packable Graft 5.0cc
Version Model NumberNB0399
Catalog NumberNB0399
Company DUNS828813290
Company NameNOVABONE PRODUCTS, LLC
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

Device Dimensions

Device Size Text, specify0
Device Size Text, specify0

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100813909010816 [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 Date2016-03-09

On-Brand Devices [MacroFORM Bioactive Packable Graft 5.0cc]

00813909010816Synthetic bone void filler for orthopedic applications
00813909010786Synthetic bone void filler for orthopedic applications

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