FDA.reportPublic FDA data

Panasonic

Primary DI
00851439007050
Brand
Panasonic
Company
PANASONIC CORPORATION OF NORTH AMERICA
Model
EW-DJ10-W551
Published
2020-06-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

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
10851439007057PackageGS15In Commercial Distribution
00851439007050PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085143900705710851439007057
00851439007050008514390070508514390070500851439007050

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
008919813
Device count
1
DM exempt
true
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851439007135PanasonicEP-MAK1-C2022026-01-22
00851439007142PanasonicEP-MAK1KU2022026-01-22
00851439007159PanasonicEP-MAN1-C2322026-01-22
00851439007166PanasonicEP-MAN1-K2322026-01-22
00851439007173PanasonicEP-MAN2-C2322026-01-22
00851439007180PanasonicEP-MAN2-K2322026-01-22
00851439007197PanasonicEP-MA117C2322026-01-22
00851439007203PanasonicEP-MA117T2322026-01-22
00851439007128PanasonicEW-DJ66-W3512025-03-10
00851439007074PanasonicEW-DJ11-A5512024-03-24
00851439007098PanasonicER-CTB1-A2022-01-31
00851439007012PanasonicEW1611W5512020-06-22
00851439007036PanasonicEW1511W5512020-06-22
00851439007043PanasonicEW1213A3512020-06-22
00851439007029PanasonicEW31092016-11-25
00851439007081PanasonicEW39012016-11-25
10851439007088PanasonicEW39012016-11-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00073950341295Waterpik Cordless Pearl Water FlosserWATER PIK, INC.EFS2026-06-09
00073950345927Waterpik Cordless Enhance 3200 Water FlosserWATER PIK, INC.EFS2026-06-09
05060640673700OrdoORDOCLUB LTDEFS2026-05-29
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