FDA.reportPublic FDA data

GuruNanda Steel Sonic TB - Rose Gold

Primary DI
00810051084702
Brand
GuruNanda Steel Sonic TB - Rose Gold
Company
Gurunanda, LLC
Model
5500A
Device description
GuruNanda Steel (Aluminum) Sonic Toothbrush - ROSE GOLD with toothbrush handle, 2 toothbrush heads, wireless charging base
Published
2024-03-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00810051084702PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810051084702008100510847028100510847020810051084702

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
079671169
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810051088649GuruNanda Aligner and Denture Cleaning FoamGNF1292026-04-29
00810051089004GuruNandaGNF1352026-01-28
00810051089479GuruNandaGNF1352026-01-28
00810051089530GuruNanda Ultrasonic Aligner Cleaning PodGN089532025-08-29
00810051088458GuruNanda Water Flosser H3200A H3200A2025-06-27
00810051081787GURUNANDA DUAL-SLICKER FLOSS PICKGNF032025-05-06
00810051083415GURUNANDA ULTIMATE 2-IN-1 FLOSS & INTERDENTAL PICKGNF012025-05-06
10810051081784GURUNANDA DUAL-SLICKER FLOSS PICKGNF032025-05-06
10810051083412GURUNANDA ULTIMATE 2-IN-1 FLOSS & INTERDENTAL PICKGNF012025-05-06
00810051085532GURUNANDA EXPANDABLE FLOSSGNF022025-05-06
00810051086515GuruNanda Water Flosser R3100AR3100A 4.02025-04-02
00810051086843GuruNanda Kids Water FlosserRK1002025-04-02
00810051087048GuruNanda Compact Water Flosser, HM100HM1002025-04-02
00810051087055GuruNanda Compact Water Flosser,HM1002025-04-02
00810051087109GuruNanda Professional Whitening Wireless Kit1.02025-04-01
00810051086317GuruNanda Compact Water Flosser HM100HM1002025-02-26
00810051084719GuruNanda Steel Sonic TB - Gold5500A2024-03-13
00810051084726GuruNanda Steel Sonic TB - Teal5500A2024-03-13
00810051084764GuruNanda Rotary Toothbrush - Lavederi20002024-03-13
00810051084771GuruNanda Rotary Toothbrush - Lavederi20002024-03-13

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