NeoForm Putty

GUDID 00812593022242

NeoForm Putty 12cc

Biogennix, LLC

Synthetic bone graft
Primary Device ID00812593022242
NIH Device Record Key812f927c-a477-4f89-9055-f9171b40b554
Commercial Distribution StatusIn Commercial Distribution
Brand NameNeoForm Putty
Version Model Number012-NFP
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
GS100812593022242 [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 Putty]

00812593022242NeoForm Putty 12cc
00812593022235NeoForm Putty 6cc
00812593022228NeoForm Putty 3cc
00812593022211NeoForm Putty 1.5cc

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