Augma Shield

GUDID 08800026800347

AUGMA BIOMATERIALS LTD

General oral wound dressing, non-animal-derived, non-sterile
Primary Device ID08800026800347
NIH Device Record Key5a69f5f4-103c-4bf2-9757-97d6efe7b539
Commercial Distribution StatusIn Commercial Distribution
Brand NameAugma Shield
Version Model NumberOB23
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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108800026800347 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MGQDressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-06-23
Device Publish Date2022-06-15

Devices Manufactured by AUGMA BIOMATERIALS LTD

07290014838062 - 3D Bond2024-03-11
08800026800347 - Augma Shield2022-06-23
08800026800347 - Augma Shield2022-06-23
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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