FDA.reportPublic FDA data

Kroger

Primary DI
00041260371462
Brand
Kroger
Company
KROGER CO., THE
Model
SQN
Device description
MOUTH GUARD REST ASSURED W/TRAY
Published
2020-05-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
10041260371469PackageGS16In Commercial Distribution
00041260371462PrimaryGS10
80041260371468Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1004126037146910041260371469
00041260371462000412603714620412603714620041260371462
8004126037146880041260371468

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
006999528
Device count
2

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00041260025747Kroger04126002574763610912025-08-05
00041260011658Kroger PJ Masks0412600116582021-01-13
00041260017957Kroger0412600179572023-01-31
00041260017964Kroger0412600179642023-01-31
00041260377501Kroger0412603775012020-08-17
00041260377518Kroger0412603775182019-10-30
00041260383809Kroger0412603838092020-06-22
00041260383816Kroger0412603838162020-06-22
00041260026850Kroger0412600268502026-03-09
60041260026852Kroger0412600268502026-03-09
60041260025749Kroger04126002574763610912025-08-05
10041260346962Kroger Blood Glucose Test Strips8000-042412016-09-24
10041260346979Kroger Blood Glucose Test Strips8000-042412016-09-24
10041260360685Kroger Premium Blood Glucose Meter8000-067682016-09-24
10041260360692Kroger Premium Blood Glucose Test Strips8000-067622016-09-24
00011110338235Kroger Pen Needles7000013332016-09-24
00041260003592Kroger Pen Needles7000147202019-06-01
00041260003608Kroger Pen Needles7000147212019-06-01
00041260343469Kroger Pen Needles7000013322016-09-24
00041260364624Kroger Pen Needles7000013312016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810036604284Rodeo DentalDental Choice Holdings LLCOBR2026-10-24
00810036604291Rodeo DentalDental Choice Holdings LLCOBR2026-10-24
00810036604307Rodeo DentalDental Choice Holdings LLCOBR2026-10-24
00810036604314Rodeo DentalDental Choice Holdings LLCOBR2026-10-24
00810036604901Rodeo DentalDental Choice Holdings LLCOBR2026-10-24
00810036604932Rodeo DentalDental Choice Holdings LLCOBR2026-10-24
00810036606783America's ToothfairyDental Choice Holdings LLCOBR2026-10-24
00810036607353America's ToothfairyDental Choice Holdings LLCOBR2026-10-24
00810036601245RestwellDental Choice Holdings LLCOBR2026-10-23
00810036601801Wake RightDental Choice Holdings LLCOBR2026-10-23
00810036604185Dental DefenseDental Choice Holdings LLCOBR2026-10-23
00810036604192Dental DefenseDental Choice Holdings LLCOBR2026-10-23
00810036604208Dental DefenseDental Choice Holdings LLCOBR2026-10-23
00810036604246Sleep RoyaltyDental Choice Holdings LLCOBR2026-10-23
00810036604253Sleep RoyaltyDental Choice Holdings LLCOBR2026-10-23
00810036604758La Mejor SonrisaDental Choice Holdings LLCOBR2026-10-23
00810036604970La Mejor SonrisaDental Choice Holdings LLCOBR2026-10-23
00810036604987La Mejor SonrisaDental Choice Holdings LLCOBR2026-10-23
00810036604994La Mejor SonrisaDental Choice Holdings LLCOBR2026-10-23
00810036605007La Mejor SonrisaDental Choice Holdings LLCOBR2026-10-23
00810036606714BruxArmorDental Choice Holdings LLCOBR2026-10-23
00810036606813ResolveDental Choice Holdings LLCOBR2026-10-23
00810036606820ResolveDental Choice Holdings LLCOBR2026-10-23
00810036606837ResolveDental Choice Holdings LLCOBR2026-10-23
00810036607520KloudDental Choice Holdings LLCOBR2026-10-23
00810036607537KloudDental Choice Holdings LLCOBR2026-10-23
00810036607544Rest In PeaceDental Choice Holdings LLCOBR2026-10-23
00810036607551Rest In PeaceDental Choice Holdings LLCOBR2026-10-23
00810036607599Sleep PeachyDental Choice Holdings LLCOBR2026-10-23
00810036607605Sleep PeachyDental Choice Holdings LLCOBR2026-10-23