FDA.reportPublic FDA data

Rite Aid

Primary DI
10118227688639
Brand
Rite Aid
Company
RITE AID CORPORATION
Model
SQN5483C1
Device description
Rest AssuredDental Protector for nightime grinding2 nite protectors, 1 storage case, 1 fitting tray
Published
2022-09-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

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
20118227688636PackageGS12In Commercial Distribution
30118227688633PackageGS16In Commercial Distribution
10118227688639PrimaryGS10
40011822768861Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2011822768863620118227688636
3011822768863330118227688633
1011822768863910118227688639
4001182276886140011822768861

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 endoscopic diagnostic procedures, 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.

Regulatory Flags#

DUNS number
014578892
Device count
2

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
05060687651877ClenchNoMore1987 MEDIA LIMITEDOBR2026-07-17
05060687651891ClenchNoMore1987 MEDIA LIMITEDOBR2026-07-17
05060687651907ClenchNoMore1987 MEDIA LIMITEDOBR2026-07-17
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