FDA.reportPublic FDA data

CVS Health

Primary DI
00050428566749
Brand
CVS Health
Company
WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
Model
SUV
Device description
Power Toothbrush Kit
Published
2020-08-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
EFWToothbrush, Manual
JEQToothbrush, Powered
JESFloss, Dental
JETPick, Massaging

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EFWToothbrush, ManualDental1
JEQToothbrush, PoweredDental1
JESFloss, DentalDental1
JETPick, MassagingDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20050428566743PackageGS16In Commercial Distribution
40050428566747PackageGS16In Commercial Distribution
00050428566749PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2005042856674320050428566743
4005042856674740050428566747
00050428566749000504285667490504285667490050428566749

GMDN Terms#

Term, Definition table
TermDefinition
Basic manual toothbrushAn instrument designed to be used by a patient to manually brush clean their teeth and gums (i.e., remove plaque, tartar, stains). It typically consists of a proximal handle and distal head with rows of bristles (e.g., nylon) grouped in separate tufts or evenly distributed. The device is typically used with toothpaste. This is a reusable device.

Regulatory Flags#

DUNS number
062312574
Device count
1
Premarket exempt
true
Kit
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00050428050460CVS Health6 Days Sooner Pregnancy TestN/A2026-06-03
00050428082102CVS Health6 Days Sooner Pregnancy TestN/A2026-06-03
00050428087268CVS Health6 Days Sooner Pregnancy TestN/A2026-06-03
00050428087589CVS Health6 Days Sooner Pregnancy TestN/A2026-06-03
00050428049556CVS Health6 Days Sooner Pregnancy TestN/A2026-06-02
00050428142516CVS0504281425162026-05-28
00050428044940CVS6158032026-05-26
00050428045770CVS6162732026-05-26
00050428046715CVS6162742026-05-26
00050428344781CVS0504283447812026-05-25
00050428250181CVS Health4969912023-09-01
00050428340769CVS Health 0504283407692026-05-20
00050428490730CVS Health5645702021-04-08
00050428000021CVS Health 0504280000212026-05-19
00050428373927CVS Health 9377672026-04-27
00050428142530CVS0504281425302026-04-23
00050428258590CVS Health8931212020-08-24
00050428265499CVS Health2414832020-02-28
00050428267189CVS Health9356862020-08-24
00050428279472CVS Health9843012020-03-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05060640673717OrdoORDOCLUB LTDJEQ2026-05-29
05060640673830OrdoORDOCLUB LTDJEQ2026-05-29
05060640673953OrdoORDOCLUB LTDJEQ2026-05-29
05060640673960OrdoORDOCLUB LTDJEQ2026-05-29
05060640673991OrdoORDOCLUB LTDJEQ2026-05-29
05060640674004OrdoORDOCLUB LTDJEQ2026-05-29
05060640674011OrdoORDOCLUB LTDJEQ2026-05-29
05060640674035OrdoORDOCLUB LTDJEQ2026-05-29
10889483565599BALLARD™SUNMED, LLCEFW2026-01-12
10070942003695GUM® CRAYOLA TWISTABLES FLOSSERSSUNSTAR AMERICAS, INC.JES2025-11-04
10371347019732Advance Dental ProductsThe Atlanta Dental Supply CompanyJES2025-10-01
10371347019749Advance Dental ProductsThe Atlanta Dental Supply CompanyJES2025-10-01
10304040192471Henry ScheinHENRY SCHEIN, INC.EFW2025-07-08
20371347019531Advance Dental ProductsThe Atlanta Dental Supply CompanyEFW2025-06-25
20371347019531Advance Dental ProductsThe Atlanta Dental Supply CompanyJES2025-06-25
00072239331057Dr. Brown'sDr. Brown's CompanyEFW2025-05-23
00072239330418Dr. Brown'sDr. Brown's CompanyEFW2025-05-22
10810063756243KIDS BUDDY ToothbrushSAFCO DENTAL SUPPLY CO.EFW2025-03-19
10810063756250Power Curve ToothbrushSAFCO DENTAL SUPPLY CO.EFW2025-03-19
10810063756267Esprit Ultra Fine ToothbrushSAFCO DENTAL SUPPLY CO.EFW2025-03-19
10810063756274Whisper Tech Ultra-Fine ToothbrushSAFCO DENTAL SUPPLY CO.EFW2025-03-19
10810063756281Power Curve ToothbrushSAFCO DENTAL SUPPLY CO.EFW2025-03-19
10810063756403Power Curve Extra-Soft ToothbrushSAFCO DENTAL SUPPLY CO.EFW2025-03-19
10810063756434KIDS BUDDY ToothbrushSAFCO DENTAL SUPPLY CO.EFW2025-03-19
10810063756588Jr Series Comfort Grip ToothbrushSAFCO DENTAL SUPPLY CO.EFW2025-03-19
10810063756595Power Curve Extra-Soft ToothbrushSAFCO DENTAL SUPPLY CO.EFW2025-03-19
10810063755567Waxed Dental FlossSAFCO DENTAL SUPPLY CO.JES2025-03-18
10810063756175Euro Tech Compact Sensitive ToothbrushSAFCO DENTAL SUPPLY CO.EFW2025-03-18
10810063756182Waxed Dental FlossSAFCO DENTAL SUPPLY CO.JES2025-03-18
10810063756199Floss PicksSAFCO DENTAL SUPPLY CO.JES2025-03-18