ossFX Moldable

GUDID 00812593021641

ossFX Moldable 6cc

Biogennix, LLC

Synthetic bone graft
Primary Device ID00812593021641
NIH Device Record Keyc16cbaa0-d255-4765-8843-e0c62e5717a7
Commercial Distribution StatusIn Commercial Distribution
Brand NameossFX Moldable
Version Model NumberAXB-OSS-06
Company DUNS832270370
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
GS100812593021641 [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 Date2023-12-21
Device Publish Date2023-12-13

On-Brand Devices [ossFX Moldable]

00812593021658ossFX Moldable 12cc
00812593021641ossFX Moldable 6cc
00812593021634ossFX Moldable 3cc
00812593021627ossFX Moldable 1.5cc

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