BiFORM Bioactive Moldable

GUDID 00850001375016

Moldable Bone Graft Matrix

COLLAGEN MATRIX, INC.

Bone matrix implant, animal-derived, bioabsorbable
Primary Device ID00850001375016
NIH Device Record Keyda9c18b2-cf89-4c36-86c3-6af7db685474
Commercial Distribution StatusIn Commercial Distribution
Brand NameBiFORM Bioactive Moldable
Version Model NumberBFBA-0500
Company DUNS176262442
Company NameCOLLAGEN MATRIX, INC.
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 Dimensions

Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100850001375016 [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 Date2019-08-30
Device Publish Date2019-08-22

On-Brand Devices [BiFORM Bioactive Moldable]

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00850001375030Moldable Bone Graft Matrix
00850001375023Moldable Bone Graft Matrix
00850001375016Moldable Bone Graft Matrix
00850001375009Moldable Bone Graft Matrix

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