FDA.reportPublic FDA data

Orapeutic

Primary DI
00037027571305
Brand
Orapeutic
Company
Forward Science Technologies LLC
Model
Orapeutic 5ct
Device description
Orapeutic is an oral hydrogel wound dressing that is applied to wounds / ulcers in the oral cavity for the management of oral pain. The gel is applied in small amounts (typically pea-sized) to cover the wound(s) as needed and dissolves over time.
Published
2024-02-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

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

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00037027571305PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00037027571305000370275713050370275713050037027571305

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
079212068
Device count
1
DM exempt
false
Premarket exempt
false
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
00370275123088OralID Fitted GlassesOralID Fitted Glasses 1ct2025-01-22
00370275123705OralID Over GlassesOralID Over Glasses 1ct2025-01-22
00370275092025FS Dispenser, StainlessStainless FS Dispenser 1ct2024-10-14
00370275091011FS DispenserFS Dispenser 1ct2024-02-21
00370275713050OrapeuticOrapeutic 5ct2024-02-14
00370275090168PerioStomPerioStom 16ct2024-02-14
00370275629047SalivaMAXSalivaMAX 30ct – 04 NDC2024-02-14
00370275850106BioStomBioStom 1ct2024-02-14
00370275850250BioStomBioStom 25ct2024-02-14
00370275850502BioStomBioStom 10ct2024-02-14
00370275123163OralIDFS-112016-10-03
00370275629030SalivaMAXSalivaMAX 30ct2016-10-03
00370275629122SalivaMAXSalivaMAX 120Ct2016-10-03
00370275629306SalivaMAXSalivaMAX 300Ct2016-10-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00368040753141Promiseb Topical CreamPrimus Pharmaceuticals, Inc.MGQ2026-05-01
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
00383160000104Dash TopicAIM MEDICAL INC.MGQ2025-05-12
00850058790060SuprelloGel4med, Inc.MGQ2025-03-25
00850058790084SuprelloGel4med, Inc.MGQ2025-03-25
00850058790091SuprelloGel4med, Inc.MGQ2025-03-25
00860013569907MuGardSoleva Pharma LLCMGQ2025-02-28
00743537000791BurnFreeWATER-JEL TECHNOLOGIES, L.L.C.MGQ2024-11-01
00743537000814BurnFreeWATER-JEL TECHNOLOGIES, L.L.C.MGQ2024-11-01
00743537000838BurnFreeWATER-JEL TECHNOLOGIES, L.L.C.MGQ2024-11-01
00743537000852Burn StopWATER-JEL TECHNOLOGIES, L.L.C.MGQ2024-11-01
00743537000913Water-JelWATER-JEL TECHNOLOGIES, L.L.C.MGQ2024-11-01
00743537000937Water-JelWATER-JEL TECHNOLOGIES, L.L.C.MGQ2024-11-01
00743537000951Water-JelWATER-JEL TECHNOLOGIES, L.L.C.MGQ2024-11-01
00743537000975Burn StopWATER-JEL TECHNOLOGIES, L.L.C.MGQ2024-11-01
00743537000999Water-JelWATER-JEL TECHNOLOGIES, L.L.C.MGQ2024-11-01
00743537001019Water-JelWATER-JEL TECHNOLOGIES, L.L.C.MGQ2024-11-01
00743537001033Water-JelWATER-JEL TECHNOLOGIES, L.L.C.MGQ2024-11-01
00743537001057Water-JelWATER-JEL TECHNOLOGIES, L.L.C.MGQ2024-11-01
00743537001071Burn StopWATER-JEL TECHNOLOGIES, L.L.C.MGQ2024-11-01
00743537001095Water-JelWATER-JEL TECHNOLOGIES, L.L.C.MGQ2024-11-01
00743537000784BurnFreeWATER-JEL TECHNOLOGIES, L.L.C.MGQ2024-11-01
00743537000807BurnFreeWATER-JEL TECHNOLOGIES, L.L.C.MGQ2024-11-01
00743537000821BurnFreeWATER-JEL TECHNOLOGIES, L.L.C.MGQ2024-11-01
00743537000845Burn StopWATER-JEL TECHNOLOGIES, L.L.C.MGQ2024-11-01
00743537000906Water-JelWATER-JEL TECHNOLOGIES, L.L.C.MGQ2024-11-01