FDA.reportPublic FDA data

Mouth-Aid

Primary DI
00199284797581
Brand
Mouth-Aid
Company
Orthonu LLC
Model
1999284797581
Catalog number
ORN0005-01
Device description
A compound intended to be used as a protective cover for the general mucosa to treat sores and ulcers.
Published
2025-03-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
NAEDressing, Wound, Hydrogel Without Drug And/Or Biologic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NAEDressing, Wound, Hydrogel Without Drug And/Or BiologicGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00199284797581PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00199284797581001992847975811992847975810199284797581

GMDN Terms#

Term, Definition table
TermDefinition
General oral wound dressing, non-animal-derivedA 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 trauma, surgery, 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., plug, sheet, gel, fluid, spray) for use in the home and clinical setting. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
125732548
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850035489062Braces Treatment Starter Kitz0850035489ORN0006-022025-06-04
00850035489079Aligner Treatment Starter Kitz0850035489ORN0006-032025-06-04
00850035489031Mouth-Aid850035489031ORN0005-012025-04-27
00850035489055Oral Relief Kitz850035489055ORN0006-012025-04-27
00850035489086Comfort Tape8500354890860RN0007-012025-04-27
00199284539792Comfort Tape™ 199284539792ORN0005-012025-03-22
00850035489000Tweakz for BracesORN0001-012022-09-19
00850035489017Tweakz for AlignersORN0002-012022-09-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
01714196112452DermaRite Medical Wound Gel- Amorphous HydrogelSion Brands LLCNAE2026-06-01
00850060751738SkinPenBellus Medical, LLCNAE2026-05-20
00860015727336KegelStar Port IncNAE2026-04-27
10840330704936ProCureTwin Med, LLCNAE2026-04-22
10840330704943ProCureTwin Med, LLCNAE2026-04-22
10840330705803ProCureTwin Med, LLCNAE2026-04-22
10840330705810ProCureTwin Med, LLCNAE2026-04-22
10840330706350ProCureTwin Med, LLCNAE2026-04-22
00324357010155Zeni MedicalFocus Health Group, Inc.NAE2026-04-13
00324357100252Zeni MedicalFocus Health Group, Inc.NAE2026-04-13
00324357104045Zeni MedicalFocus Health Group, Inc.NAE2026-04-13
00743537000456First ResponderWATER-JEL TECHNOLOGIES, L.L.C.NAE2026-02-19
00743537000470MilitaryWATER-JEL TECHNOLOGIES, L.L.C.NAE2026-02-19
10197344017508MEDLINEMEDLINE INDUSTRIES, INC.NAE2025-10-23
00858071004478Natural Shield Wound Dressing, 1oz brush onKericure Inc.NAE2025-10-06
00858071004553Natural Shield Wound Dressing, 1oz sprayKericure Inc.NAE2025-10-06
20192253040156KendallCardinal Health 200, LLCNAE2025-09-26
00197998326882Solventum™ Nu-Gel™Solventum Germany GmbHNAE2025-09-22
00197998326967Solventum™ Nu-Gel™Solventum Germany GmbHNAE2025-09-22
15056860000034Gentell Hydrogel Sheet DressingGentell, LLCNAE2025-08-21
15056860000041Gentell Hydrogel Sheet DressingGentell, LLCNAE2025-08-21
15056860000058Gentell Hydrogel Sheet DressingGentell, LLCNAE2025-08-21
10197344110162MEDLINEMEDLINE INDUSTRIES, INC.NAE2025-08-04
06974600043672KONLIDASuzhou Konlida Medical Supplies Co., Ltd.NAE2025-07-28
M689HHWSK02050Wound Seal KitSafeguard US Operating, LLCNAE2025-06-24
06971292003694AUVONShenzhen Yuwen E-Commerce Co., Ltd.NAE2025-06-19
06971292003700AUVONShenzhen Yuwen E-Commerce Co., Ltd.NAE2025-06-19
00810040134692SimpuritySAFE N' SIMPLE LLCNAE2025-06-17
00810040134708SimpuritySAFE N' SIMPLE LLCNAE2025-06-17
00361554005614GentellGentell, LLCNAE2025-02-14