FDA.reportPublic FDA data

Rexall

Primary DI
00850010842882
Brand
Rexall
Company
DOLGENCORP, LLC
Model
25454901
Device description
Rexall Enamel Protect Kids Extra Soft 2PK
Published
2020-06-25
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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EFWToothbrush, ManualDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850010842882PrimaryGS10
50850010842887Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850010842882008500108428828500108428820850010842882
5085001084288750850010842887

GMDN Terms#

Term, Definition table
TermDefinition
Basic manual toothbrushAn instrument designed to be used by a person to manually brush clean their teeth and gums (i.e., remove plaque, tartar, stains). It typically consists of a proximal handle and distal head to which is attached two or more rows of bristles (e.g., nylon) grouped in separate tufts, in rows, or evenly distributed. The device is typically used with toothpaste; it is normally available [non-prescription] over-the-counter (OTC). This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
068331990
Device count
2
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00017276224771Rexall0172762247712020-09-07
00834533001414DG HealthBDGGC362026-03-23
00834533001445DG HealthBDGGS182026-03-23
10834533001411DG HealthBDGGC362026-03-23
10834533001442DG HealthBDGGS182026-03-23
00751774000030DG Health20002256N/A2026-02-20
10751774000037DG Health20002256N/A2026-02-20
00751774242461Rexall One Step Pregnancy Test2020-07-10
00751774250473Rexall One Step Pregnancy Test2020-07-10
00197344018737RexallDG4335DG43352025-10-02
00751774260472Dollar GeneralOne Step Pregnancy Test2025-05-09
00751774262469DG HealthOne Step Pregnancy TestN/A2025-05-09
00845717090001Rexall77-35277-3522016-09-24
00845717773591Rexall77-35977-3592016-09-24
10751774260479Dollar GeneralOne Step Pregnancy Test2025-05-09
10751774262466DG HealthOne Step Pregnancy TestN/A2025-05-09
00646011887409Rexall Sterile Saline Wound Wash88-50740-200-002024-10-04
00197344110059RexallDG4345DG43452024-08-08
10197344110056RexallDG4345DG43452024-08-08
00751774250787DG healthOne Step Pregnancy TestN/A2023-10-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00072239332559Dr. Brown'sDr. Brown's CompanyEFW2026-06-08
00072239332566Dr. Brown'sDr. Brown's CompanyEFW2026-06-08
00072239332573Dr. Brown'sDr. Brown's CompanyEFW2026-06-08
00072239332580Dr. Brown'sDr. Brown's CompanyEFW2026-06-08
00072239334812Dr. Brown'sDr. Brown's CompanyEFW2026-06-08
00072239334829Dr. Brown'sDr. Brown's CompanyEFW2026-06-08
00072239334836Dr. Brown'sDr. Brown's CompanyEFW2026-06-08
00072239328002Dr. Brown'sDr. Brown's CompanyEFW2026-06-05
00072239328149Dr. Brown'sDr. Brown's CompanyEFW2026-06-05
00072239330050Dr. Brown'sDr. Brown's CompanyEFW2026-06-05
00072239332313Dr. Brown'sDr. Brown's CompanyEFW2026-06-05
00072239332320Dr. Brown'sDr. Brown's CompanyEFW2026-06-05
00072239332535Dr. Brown'sDr. Brown's CompanyEFW2026-06-05
00072239332542Dr. Brown'sDr. Brown's CompanyEFW2026-06-05
00072239333129Dr. Brown'sDr. Brown's CompanyEFW2026-06-05
10889483565599BALLARD™SUNMED, LLCEFW2026-01-12
00070942007368GUM Technique Sensitive CleanSUNSTAR AMERICAS, INC.EFW2025-08-15
00070942007412GUM Technique Sensitive CleanSUNSTAR AMERICAS, INC.EFW2025-08-15
10304040192471Henry ScheinHENRY SCHEIN, INC.EFW2025-07-08
20371347019531Advance Dental ProductsThe Atlanta Dental Supply CompanyEFW2025-06-25
00072239331057Dr. Brown'sDr. Brown's CompanyEFW2025-05-23
00072239330418Dr. Brown'sDr. Brown's CompanyEFW2025-05-22
00070942006378GUM Technique Sensitive CleanSUNSTAR AMERICAS, INC.EFW2025-05-19
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