Home GUDID 00199874891422 MuReva OM™
Primary DI 00199874891422
Brand MuReva OM™
Company MuReva Phototherapy Inc.
Model 1000329
Device description MuReva OM™ Over-Tongue Mouthpiece Attachment, Single-Use Sterile 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 true
Single use true Product Codes# Code, Name table Code Name SGQ Intraoral Phototherapy Device
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class SGQ Intraoral Phototherapy Device Dental 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 10199874891429 Package GS1 36 In Commercial Distribution 00199874891422 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 10199874891429 10199874891429 00199874891422 00199874891422 199874891422 0199874891422
GMDN Terms# Term, Definition table Term Definition Red-light phototherapy unit, professional An 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 true 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 true Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00199874241616 MuReva OM™ MuReva Phototherapy Inc. SGQ 2026-06-08 00199874868073 MuReva OM™ MuReva Phototherapy Inc. SGQ 2026-06-08 00199874947471 MuReva OM™ MuReva Phototherapy Inc. SGQ 2026-06-08