FDA.reportPublic FDA data

GUM®

Primary DI
00070942126120
Brand
GUM®
Company
SUNSTAR AMERICAS, INC.
Model
2272
Catalog number
RQ; PQ
Device description
CRAYOLA POWER TOOTHBRUSH SOFT
Published
2022-11-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JEQTOOTHBRUSH, POWERED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JEQToothbrush, PoweredDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00070942006729PackageGS12In Commercial Distribution
10070942126127PackageGS14In Commercial Distribution
00070942126120PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00070942006729000709420067290709420067290070942006729
1007094212612710070942126127
00070942126120000709421261200709421261200070942126120

GMDN Terms#

Term, Definition table
TermDefinition
Basic electric toothbrushAn electrically-powered device designed to be used by a patient to brush clean their teeth and gums (i.e., remove plaque, tartar, stains). It typically consists of a proximal handle and an exchangeable distal head with rows of bristles (e.g., nylon) grouped in separate tufts or evenly distributed. The device provides automated bristle movement (e.g., rotary or vibratory) intended to augment brushing, and is typically used with toothpaste. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height203.9Millimeter

Contacts#

Phone, Email table
PhoneEmail
+1(800)777-3101contact.us@us.sunstar.com

Regulatory Flags#

DUNS number
025066358
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00070942007160GUM®888PCRX2026-10-08
07640164360072GUIDORC11-0082015-10-22
07640164360089GUIDORC11-0182015-10-22
07640164360096GUIDORC11-0782015-10-22
07640164360140GUIDORC11-0072015-10-22
10070942003695GUM® CRAYOLA TWISTABLES FLOSSERS853PA, PX2025-11-04
10070942751572GUM®2014PQ, PQA, PQB2022-11-10
10070942751619GUM®1115PQA; PQBX2022-11-10
70070942751703GUM®3210PQX2022-11-10
00070942302159GUM®1812RQTX2022-11-10
00070942306515GUM®897RQ75, RZDX2022-11-10
00070942008334GUM®875SM2026-07-28
00070942005265GUM®3615BQ2023-01-26
00070942006491GUM®3615PQA2023-12-07
00070942005425GUM®4100UTWA2023-06-14
00070942005432GUM®4100UTBA2023-06-14
00070942008822GUM® Expanding Floss2030R42026-05-01
00070942008952GUM® Professional Clean Floss1820RA2026-04-30
00070942783354GUM®9934RA2024-03-12
00070942007368GUM Technique Sensitive Clean527TPA12025-08-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06938320799899SEAGONingbo Seago Electric Co.,Ltd.JEQ2026-10-12
06938320799905SEAGONingbo Seago Electric Co.,Ltd.JEQ2026-10-12
06938320799912SEAGONingbo Seago Electric Co.,Ltd.JEQ2026-10-12
06938320799929SEAGONingbo Seago Electric Co.,Ltd.JEQ2026-10-12
06938320799936SEAGONingbo Seago Electric Co.,Ltd.JEQ2026-10-12
06938320799943SEAGONingbo Seago Electric Co.,Ltd.JEQ2026-10-12
06938320799950SEAGONingbo Seago Electric Co.,Ltd.JEQ2026-10-12
06938320799967SEAGONingbo Seago Electric Co.,Ltd.JEQ2026-10-12
06938320799981SEAGONingbo Seago Electric Co.,Ltd.JEQ2026-10-12
06938320799998SEAGONingbo Seago Electric Co.,Ltd.JEQ2026-10-12
05060640673731OrdoORDOCLUB LTDJEQ2026-09-22
05060640673748OrdoORDOCLUB LTDJEQ2026-09-22
05060640674097OrdoORDOCLUB LTDJEQ2026-09-22
05060640674141OrdoORDOCLUB LTDJEQ2026-09-22
05060640674486OrdoORDOCLUB LTDJEQ2026-09-22
00072239332290Dr. Brown'sDr. Brown's CompanyJEQ2026-06-05
00072239332511Dr. Brown'sDr. Brown's CompanyJEQ2026-06-05
00072239332528Dr. Brown'sDr. Brown's CompanyJEQ2026-06-05
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
00073950323734WaterPik Sensonic Toothbrush Brush Heads (3pk)WATER PIK, INC.JEQ2026-03-03
00197344175874MEDLINEMEDLINE INDUSTRIES, INC.JEQ2026-01-22
00197344175881MEDLINEMEDLINE INDUSTRIES, INC.JEQ2026-01-22
00194346288038EQUATEWAL-MART STORES, INC.JEQ2024-11-15