NeoForm Strip

GUDID 00812593022266

NeoForm Strip Large

Biogennix, LLC

Synthetic bone graft
Primary Device ID00812593022266
NIH Device Record Keye353b5f1-5ba3-45c1-a35c-fbecfbde7ccb
Commercial Distribution StatusIn Commercial Distribution
Brand NameNeoForm Strip
Version Model Number020-NFS
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
GS100812593022266 [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 Date2023-12-20
Device Publish Date2023-12-12

On-Brand Devices [NeoForm Strip]

00812593022266NeoForm Strip Large
00812593022259NeoForm Strip Medium

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