FDA.reportPublic FDA data

Augma Shield

Primary DI
08800026800347
Brand
Augma Shield
Company
AUGMA BIOMATERIALS LTD
Model
OB23
Published
2022-06-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
MGQDressing, Wound And Burn, Hydrogel W/Drug And/Or Biologic
OLROral Wound Dressing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MGQDressing, Wound And Burn, Hydrogel W/Drug And/Or BiologicUnknownU
OLROral Wound DressingUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K211851000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K211851000Ora-AidTbm Corporation2022-01-11OLR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800026800347PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800026800347088000268003478800026800347

GMDN Terms#

Term, Definition table
TermDefinition
General oral wound dressing, non-animal-derived, non-sterileA non-sterile compound intended to be used as a protective cover for the general oral mucosa to treat mouth wounds and sores such as ulcers and lesions caused by radiotherapy/chemotherapy or dental prostheses/orthodontic braces; it may in addition be intended to treat mucosal irritations/inflammation, dryness, and/or gingivitis, or to prevent mouth wounds/lesions. It consists primarily of one or more plant-derived and/or (bio)synthetic compound(s) [e.g., polysaccharides, hyaluronic acid, dimethicone] and is supplied in various forms (e.g., gel, fluid, spray) for use in the home or a clinical setting. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
533432352
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290014838116Bond ApatiteHA-BB-LMM-NoEU2026-02-04
07290014838123Bond ApatiteHA-BB-LAM-NoEU2026-02-04
072900148381783D Bond+3D-ND-LMM-NoEU2026-02-04
072900148381853D Bond+3D-ND-LAM-NoEU2026-02-04
072900148381923D Bond+3D-ND-LAA-NoEU2026-02-04
072900148382083D BondDD-100-LMM2026-02-04
072900148382153D BondDD-100-LAM2026-02-04
07290014838031Bond ApatiteHA-BB-Pack1-NoEU2020-11-17
07290014838130Bond ApatiteHA-BB-LAA-NoEU2026-01-15
072900148380173D BondDD2-1002015-09-10
07290014838024Bond ApatiteHA-BB-Pack12015-09-10
072900148380003D Bond DD2-0502015-09-10
072900148380623D BondDD-1002024-03-03
072900148380553D Bond+3D-ND-050-NoEU2022-06-10
172900148380073D Bond DD2-0502015-09-10
172900148380143D BondDD2-1002015-09-10
17290014838021Bond ApatiteHA-BB-Pack12015-09-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00368040753141Promiseb Topical CreamPrimus Pharmaceuticals, Inc.MGQ2026-05-01
04714691213958VeraFill Dental Collagen Wound DressingMAXIGEN BIOTECH INC.OLR2026-03-30
04714691213934VeraFill Dental Collagen Wound DressingMAXIGEN BIOTECH INC.OLR2025-11-04
00850058790114RV-X1Gel4med, Inc.MGQ2025-10-17
00850058790121RV-X1Gel4med, Inc.MGQ2025-10-17
00850058790138G4Derm PlusGel4med, Inc.MGQ2025-10-17
00850058790145G4Derm PlusGel4med, Inc.MGQ2025-10-17
00850058790152G4Derm PlusGel4med, Inc.MGQ2025-10-17
04714691213903HealiAid Dental Collagen Wound DressingMAXIGEN BIOTECH INC.OLR2025-09-30
04714691213910HealiAid Dental Collagen Wound DressingMAXIGEN BIOTECH INC.OLR2025-09-30
04714691213897HealiAid Dental Collagen Wound DressingMAXIGEN BIOTECH INC.OLR2025-09-22
04714691213859HealiAid Dental Collagen Wound DressingMAXIGEN BIOTECH INC.OLR2025-06-12
00383160000104Dash TopicAIM MEDICAL INC.MGQ2025-05-12
00850058790060SuprelloGel4med, Inc.MGQ2025-03-25
00850058790084SuprelloGel4med, Inc.MGQ2025-03-25
00850058790091SuprelloGel4med, Inc.MGQ2025-03-25
04714691213705Guide Plug Collagen Wound Dressing MAXIGEN BIOTECH INC.OLR2025-03-13
04714691213712Guide Plug Collagen Wound DressingMAXIGEN BIOTECH INC.OLR2025-03-13
04714691213682Guide Plug Collagen Wound Dressing MAXIGEN BIOTECH INC.OLR2025-03-13
04714691213699Guide Plug Collagen Wound DressingMAXIGEN BIOTECH INC.OLR2025-03-13
00860013569907MuGardSoleva Pharma LLCMGQ2025-02-28
00860013569907MuGardSoleva Pharma LLCOLR2025-02-28
04714691213552HealiAid Dental Collagen Wound DressingMAXIGEN BIOTECH INC.OLR2024-11-18
04714691213569HealiAid Dental Collagen Wound DressingMAXIGEN BIOTECH INC.OLR2024-11-18
04714691213576HealiAid Dental Collagen Wound DressingMAXIGEN BIOTECH INC.OLR2024-11-18
04714691850443Curagen collagen wound dressingMAXIGEN BIOTECH INC.OLR2024-11-18
04714691850450Curagen collagen wound dressingMAXIGEN BIOTECH INC.OLR2024-11-18
04714691213521HealiAid Dental Collagen Wound DressingMAXIGEN BIOTECH INC.OLR2024-11-18
04714691213538HealiAid Dental Collagen Wound DressingMAXIGEN BIOTECH INC.OLR2024-11-18
04714691213545HealiAid Dental Collagen Wound DressingMAXIGEN BIOTECH INC.OLR2024-11-18