MuReva OM™

Primary DI
00199874947471
Brand
MuReva OM™
Company
MuReva Phototherapy Inc.
Model
1000307
Device description
MuReva OM™ Reprocessing Fixture Kit, Accessory
Published
2026-06-08
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
SGQIntraoral Phototherapy Device

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
SGQIntraoral Phototherapy DeviceDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN240077000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN240077000MuReva OM™Mureva Phototherapy, Inc.2025-11-26SGQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00199874947471PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00199874947471001998749474711998749474710199874947471

GMDN Terms#

Term, Definition table
TermDefinition
Red-light phototherapy unit, professionalAn electrically-powered device designed to emit red light for phototherapy primarily to accelerate healing of cutaneous/mucosal wounds, treat mild skin disorders (e.g., mild acne), intraoral or nasal conditions, and/or treat musculoskeletal symptoms (e.g., pain, spasm, stiffness) through modification of cellular metabolism and/or improvement of blood circulation. It is a non-wearable device which may be in the form of a hand-held, freestanding or mounted unit, and is intended to be used by a healthcare professional in a clinical setting.

Regulatory Flags#

DUNS number
117861215
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
true
Expiration date on label
false
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
00199874241616MuReva OM™10001552026-06-08
00199874868073MuReva OM™10003002026-06-08
00199874891422MuReva OM™10003292026-06-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199874241616MuReva OM™MuReva Phototherapy Inc.SGQ2026-06-08
00199874868073MuReva OM™MuReva Phototherapy Inc.SGQ2026-06-08
00199874891422MuReva OM™MuReva Phototherapy Inc.SGQ2026-06-08