FDA.reportPublic FDA data

Rite Aid Pharmacy

Primary DI
80011822768869
Brand
Rite Aid Pharmacy
Company
RITE AID CORPORATION
Model
SQN
Device description
Rest Assured Mouth Guard
Published
2020-06-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
OBRMouthguard, Over-The-Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OBRMouthguard, Over-The-CounterUnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00011822768863PrimaryGS10
80011822768869Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00011822768863000118227688630118227688630011822768863
8001182276886980011822768869

GMDN Terms#

Term, Definition table
TermDefinition
Mouthguard, reusableA prefabricated oral device designed to protect the teeth, bones, and tissues of the mouth from damage due to impact/trauma typically during contact sports, and/or to prevent teeth grinding/clenching (bruxism). It is made of standard, preformed materials or items for adaptation to/direct insertion into the mouth; some types are referred to as nightguards or bite raising appliances. This is a reusable device intended for single-patient use.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
014578892
Device count
2
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
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
00011822037785Rite Aid Pharmacy0118220377852020-02-24
00011822089210Rite Aid 0118220892102021-01-19
00011822089227Rite Aid 0118220892272021-01-19
00011822137010Rite Aid Pharmacy0118221370102020-01-30
00011822372091Rite Aid Pharmacy0118223720912020-04-29
00011822411219Rite Aid Pharmacy0118224112192020-01-30
00011822411554Rite Aid Pharmacy01182241155480190102021-05-24
00011822430500Rite Aid Pharmacy0118224305002020-02-10
00011822455404Rite Aid Pharmacy01182245540480189862021-05-24
00011822565561Rite Aid Pharmacy035655603565562016-09-24
00011822643146Rite Aid Pharmacy0118226431462021-06-21
00011822673686Rite Aid Pharmacy0118226736862020-01-30
00011822685948Rite Aid Pharmacy0118226859482020-01-30
00011822729475Rite Aid Pharmacy0118227294752020-01-30
00011822782128Rite Aid Pharmacy0118227821282020-04-29
00011822782135Rite Aid Pharmacy0118227821352020-04-29
00011822855617Rite Aid Pharmacy0118228556172020-08-10
00011822894807Rite Aid 0118228948072021-01-19
00011822037815Rite Aid Pharmacy01182203781503719362021-05-11
00011822001656Rite Aid80245132025-01-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860013500733Custom Night GuardGrindGuard Inc.OBR2026-03-05
00860013500740Custom Night GuardGrindGuard Inc.OBR2026-03-05
00860014754609Owl Night GuardOWL DENTAL LAB INCOBR2026-03-05
00860014754616Owl Night GuardOWL DENTAL LAB INCOBR2026-03-05
00860014754623Owl Night GuardOWL DENTAL LAB INCOBR2026-03-05
00860015217721enCore Night GuardENCORE LABORATORY LLCOBR2026-03-02
00860015217738enCore Night GuardENCORE LABORATORY LLCOBR2026-03-02
00860015217707enCore Night GuardENCORE LABORATORY LLCOBR2026-01-08
00692121032055SleepRightSplintek Inc.OBR2025-12-17
00692121032062SleepRightSplintek Inc.OBR2025-12-17
00692121032246SleepRightSplintek Inc.OBR2025-12-17
00692121035438SleepRightSplintek Inc.OBR2025-12-17
00860013500702Custom Night GuardGrindGuard Inc.OBR2025-03-17
00087701190667Good Neighbor PharmacyAmerisourcebergen Drug CorporationOBR2025-03-03
20087701190661Good Neighbor PharmacyAmerisourcebergen Drug CorporationOBR2025-03-03
00195515045247Amazon BasicsAMAZON.COM SERVICES LLCOBR2025-01-25
10195515045244Amazon BasicsAMAZON.COM SERVICES LLCOBR2025-01-25
00651080651523PlackersRANIR, LLCOBR2024-04-26
10651080651520PlackersRANIR, LLCOBR2024-04-26
00713733567404MeijerMEIJER, INC.OBR2024-04-17
00050428270691CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDOBR2024-04-16
10050428270698CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDOBR2024-04-16
00311917046877WalgreensWALGREEN CO.OBR2024-01-18
10311917046874WalgreensWALGREEN CO.OBR2024-01-18
00692121035216SleepRightSplintek Inc.OBR2023-08-30
00866618000036GrindRelief PROGrind Guard Technologies, L.L.C.OBR2023-07-18
00866618000043GrindRelief PROGrind Guard Technologies, L.L.C.OBR2023-07-18
00866618000050GrindRelief PROGrind Guard Technologies, L.L.C.OBR2023-07-18
10866618000033GrindRelief PROGrind Guard Technologies, L.L.C.OBR2023-07-18
00858286007646SOVAAkervall Technologies, Inc.OBR2023-02-07