3D Bond+

GUDID 07290014838055

AUGMA BIOMATERIALS LTD

Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft Synthetic bone graft
Primary Device ID07290014838055
NIH Device Record Key431145c6-c4ce-4e39-a8bb-4cd5c90af578
Commercial Distribution StatusIn Commercial Distribution
Brand Name3D Bond+
Version Model Number3D-ND-050-NoEU
Company DUNS533432352
Company NameAUGMA BIOMATERIALS LTD
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 Datetrue
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
GS107290014838055 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LYCBone Grafting Material, Synthetic

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-06-21
Device Publish Date2022-06-10

Devices Manufactured by AUGMA BIOMATERIALS LTD

07290014838062 - 3D Bond2024-03-11
08800026800347 - Augma Shield2022-06-23
07290014838055 - 3D Bond+2022-06-21
07290014838055 - 3D Bond+2022-06-21
17290014838007 - 3D Bond 2018-07-06 ‎3D Bond is a synthetic, osteoconductive, ‎bioresorbable graft binder cement composed ‎of biphasic Calcium Sulfate in a g
17290014838014 - 3D Bond2018-07-06 ‎3D Bond is a synthetic, osteoconductive, ‎bioresorbable graft binder cement composed ‎of biphasic Calcium Sulfate in a g
17290014838021 - Bond Apatite2018-03-29 Bond Apatite® is a synthetic, ‎osteoconductive, composite graft cement ‎composed of biphasic calcium sulfate and ‎hydroxy

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