Profiniti

GUDID 00813954025117

Moldable Graft

COLLAGEN MATRIX, INC.

Bone matrix implant, animal-derived, bioabsorbable
Primary Device ID00813954025117
NIH Device Record Key18355932-4ad8-4c36-ad78-b82ca82cc2e3
Commercial Distribution StatusIn Commercial Distribution
Brand NameProfiniti
Version Model NumberAFMP050
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

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Device Identifiers

Device Issuing AgencyDevice ID
GS100813954025117 [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 Date2022-09-12
Device Publish Date2022-09-02

On-Brand Devices [Profiniti]

00813954025117Moldable Graft
00813954025100Moldable Graft
00813954025353Moldable Putty Bone Graft Matrix
00813954025346Moldable Putty Bone Graft Matrix
00813954025339Moldable Putty Bone Graft Matrix

Trademark Results [Profiniti]

Mark Image

Registration | Serial
Company
Trademark
Application Date
PROFINITI
PROFINITI
97522651 not registered Live/Pending
Coastal Biologics, LLC
2022-07-27

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