SynOss Ridge

GUDID 00813954021805

Synthetic Mineral-Collagen Composite For Ridge Augmentation

COLLAGEN MATRIX, INC.

Dental bone matrix implant, synthetic Dental bone matrix implant, synthetic
Primary Device ID00813954021805
NIH Device Record Key6e663106-65e7-4dd2-9b26-281d01138526
Commercial Distribution Discontinuation2019-09-13
Commercial Distribution StatusNot in Commercial Distribution
Brand NameSynOss Ridge
Version Model NumberRAB2515
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 Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100813954021805 [Primary]

FDA Product Code

NPMBone Grafting Material, Animal Source

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-09-16
Device Publish Date2016-08-01

Devices Manufactured by COLLAGEN MATRIX, INC.

10813954026135 - EvoBone Plug2024-04-05 Bone Graft Composite Plug
10813954026142 - EvoBone Plug2024-04-05 Bone Graft Composite Plug
00813954025254 - MatrixMem2024-03-20 Regenerative Collagen Dental Membrane 15mm x 20mm
00813954025261 - MatrixMem2024-03-20 Regenerative Collagen Dental Membrane 20mm x 30mm
00813954025278 - MatrixMem2024-03-20 Regenerative Collagen Dental Membrane 30mm x 40mm
00813954026046 - ASYN Puck2023-11-08 Moldable Bioactive Bone Graft
00813954026053 - ASYN Puck2023-11-08 Moldable Bioactive Bone Graft
00813954026060 - ASYN Strip2023-11-08 Moldable Bioactive Bone Graft

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