nanOss Strata Moldable

GUDID 00812593022914

nanOss Strata Moldable 1.5cc

Biogennix, LLC

Synthetic bone graft
Primary Device ID00812593022914
NIH Device Record Keyecd99d3b-a6e1-429d-a676-112231d7a8a7
Commercial Distribution StatusIn Commercial Distribution
Brand NamenanOss Strata Moldable
Version Model Number450615
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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100812593022914 [Primary]

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 Date2025-09-26
Device Publish Date2025-09-18

On-Brand Devices [nanOss Strata Moldable]

00812593022945nanOss Strata Moldable 12cc
00812593022938nanOss Strata Moldable 6cc
00812593022921nanOss Strata Moldable 3cc
00812593022914nanOss Strata Moldable 1.5cc

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