FDA.reportPublic FDA data

Aura Bright

Primary DI
09358910000018
Brand
Aura Bright
Company
BRANDFARM PTY. LTD.
Model
AB2
Device description
Aura Bright Cordless Grand Water Jet Rose Pink
Published
2022-04-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
EFSUnit, Oral Irrigation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EFSUnit, Oral IrrigationDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09358910000018PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09358910000018093589100000189358910000018

GMDN Terms#

Term, Definition table
TermDefinition
Water jet flosser/sonic electric toothbrushAn electrically-powered device intended to provide a high-pressure water jet for dental flossing (removal of plaque and/or debris from between teeth) using a dedicated handpiece, and to provide (sonic) vibration for toothbrush heads attached to the handpiece for brushing the teeth. It is normally available [non-prescription] over-the-counter (OTC) fo use in the home or healthcare facility.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
759735108
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09358910000148Aura BrightAB172024-12-02
09358910000155Aura BrightAB182024-12-02
09358910000087Aura BrightAB92022-08-15
09358910000100Aura BrightAB102022-08-15
09358910000124Aura BrightAB92022-08-15
09358910000131Aura BrightAB102022-08-15
09358910000001Aura BrightAB12022-04-01
09358910000025Aura BrightAB32022-04-01
09358910000032Aura BrightAB42022-04-01
09358910000049Aura BrightAB52022-04-01
09358910000056Aura BrightAB62022-04-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00073950345897Waterpik Cordless Enhance 3200 Water FlosserWATER PIK, INC.EFS2026-05-26
00073950346122Waterpik Cordless Water FlosserWATER PIK, INC.EFS2026-05-26
00073950346788Waterpik Cordless Pulse 3100 Water FlosserWATER PIK, INC.EFS2026-05-26
00073950347167Waterpik Cordless 1200 Water FlosserWATER PIK, INC.EFS2026-05-26
08809260475687Oral irrigation unitSaeshin Precision Co., Ltd.EFS2026-05-21
08809260475694Oral irrigation unitSaeshin Precision Co., Ltd.EFS2026-05-21
00056310343412WaterPik Cordless Plus 5000 Water FlosserWATER PIK, INC.EFS2026-04-09
08052141311806Irrigation LineOMNIA SRLEFS2026-03-27
08052141312025Irrigation LineOMNIA SRLEFS2026-03-27
08052141312780Irrigation LineOMNIA SRLEFS2026-03-27
08052141312865Irrigation LineOMNIA SRLEFS2026-03-27
08052141312940Irrigation LineOMNIA SRLEFS2026-03-27
08052141313602Irrigation LineOMNIA SRLEFS2026-03-27
00073950255554Handle/Hose Assembly Repair KitWATER PIK, INC.EFS2026-03-13
00073950338226Waterpik Cordless Gem 5100 Water FlosserWATER PIK, INC.EFS2026-03-13
10073950255551Handle/Hose Assembly Repair KitWATER PIK, INC.EFS2026-03-13
10073950338223Waterpik Cordless Gem 5100 Water FlosserWATER PIK, INC.EFS2026-03-13
00197344199764MEDLINEMEDLINE INDUSTRIES, INC.EFS2026-03-06
10197344199761MEDLINEMEDLINE INDUSTRIES, INC.EFS2026-03-06
00197344199771MEDLINEMEDLINE INDUSTRIES, INC.EFS2026-02-25
10197344199778MEDLINEMEDLINE INDUSTRIES, INC.EFS2026-02-25
00050428005408CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDEFS2026-02-13
00050428005415CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDEFS2026-02-13
00050428005422CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDEFS2026-02-13
05060640672406OrdoORDOCLUB LTDEFS2026-02-06
00073950338189Waterpik Cordless Gem 5100 Water FlosserWATER PIK, INC.EFS2026-02-03
00100739503381Waterpik Cordless Gem 5100 Water FlosserWATER PIK, INC.EFS2026-02-03
00056310343870Waterpik Cordless 1000 Water Flosser (2pk)WATER PIK, INC.EFS2026-01-28
00056310343900Waterpik Cordless 1000 Water Flosser (2pk)WATER PIK, INC.EFS2026-01-28
10073950278192Water Pik Ultra Waterflosser (3pk)WATER PIK, INC.EFS2026-01-12