TRIOSITE 00-1109-005-25

GUDID H132001109005251

Synthetic Bone Resorbable Graft Disc

BIOMATLANTE

Bone matrix implant, synthetic
Primary Device IDH132001109005251
NIH Device Record Key2177ea70-1162-4a07-b282-3c2767306030
Commercial Distribution StatusIn Commercial Distribution
Brand NameTRIOSITE
Version Model Number00-1109-005-25
Catalog Number00-1109-005-25
Company DUNS493710719
Company NameBIOMATLANTE
Device Count1
DM Exempttrue
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 Datetrue
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
HIBCCH132001109005251 [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 StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-05-11

On-Brand Devices [TRIOSITE]

H132001109132151Synthetic Bone Resorbable Graft Cone 12
H132001109115021Synthétic Bone Resorbable Graft Granules 2-4mm 16cc
H132001109115011Synthetic bone Resorbable Graft Granules 2-3mm
H132001109114021Synthetic Bone Resorbable Graft Stick 5x5x20mm
H132001109113011Synthetic Bone Resorbable Graft Stick 5x5x10mm
H132001109085151Synthetic Bone Resorbable Graft Cone
H132001109006121Synthetic Bone Resorbable Graft Wedge 12mm
H132001109005251Synthetic Bone Resorbable Graft Disc
H132001109005101Synthetic Bone Resorbable Graft Wedge 10mm
H132001109005031Synthetic Bone Resorbable Graft Granules 2-3mm 5cc
H132001109000481Synthetic Bone Resorbable Graft Wedge 8mm
H132001109000361Synthetic Bone Resorbable Graft Wedge 6mm
H132000060130001Synthetic Bone Resorbable Graft Granules 0.5-1mm
H131001109114011Synthetic Bone Resorbable Graft Stick 5x5x20mm
H131001109113021synthetic Bone Resorbable Graft Stick 5x5x10mm

Trademark Results [TRIOSITE]

Mark Image

Registration | Serial
Company
Trademark
Application Date
TRIOSITE
TRIOSITE
75168963 not registered Dead/Abandoned
ZIMMER, INC.
1996-09-19
TRIOSITE
TRIOSITE
73683260 1557566 Dead/Cancelled
ZIMMER S.A.
1987-09-09

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