osteoSPAN 100-30G

GUDID 00812593020620

1-4mm osteoSPAN Granules

BIOGENNIX LLC

Synthetic bone graft
Primary Device ID00812593020620
NIH Device Record Keycd747b19-b69d-41b2-a4fc-3481f2b927af
Commercial Distribution StatusIn Commercial Distribution
Brand NameosteoSPAN
Version Model Number100-30G
Catalog Number100-30G
Company DUNS021486533
Company NameBIOGENNIX 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 Identifiers

Device Issuing AgencyDevice ID
GS100812593020620 [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 Date2016-12-19

On-Brand Devices [osteoSPAN]

008125930206201-4mm osteoSPAN Granules
008125930206139x6x40mm osteoSPAN Blocks
008125930206066x6x40mm osteoSPAN Blocks

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