FDA.reportPublic FDA data

Ordo

Primary DI
05060640672406
Brand
Ordo
Company
ORDOCLUB LTD
Model
HSWF01-MG
Published
2026-02-06
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
05060640672406PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060640672406050606406724065060640672406

GMDN Terms#

Term, Definition table
TermDefinition
Water jet flosserAn 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. 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
223011861
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060640673342OrdoOKB-AUG2026-02-06
05060640673359OrdoOKB-SMR2026-02-06
05060640673366OrdoOKB-DAX2026-02-06
05060640673403OrdoSKB-APO2026-02-06
05060640673472OrdoOKB-JOE2026-02-06
05060640672468OrdoSKC-CAM-HW252025-09-05
05060640672475OrdoSKC-ZUM2025-09-05
05060640672482OrdoSKB-EMY2025-09-05
05060640672505OrdoSKC-CAM-XM252025-09-05
05060640672512OrdoSKC-ZOZ2025-09-05
05060640672529OrdoSKB-JOE2025-09-05
05060640672949OrdoSE-CG2025-09-05
05060640672956OrdoSE-PP2025-09-05
05060640672963OrdoSE-SN2025-09-05
05060640672970OrdoSE-FF2025-09-05
05060640672987OrdoSE-CB2025-09-05
05060640672994OrdoSE-LS2025-09-05
05060640673007OrdoSE-WGL2025-09-05
05060640673014OrdoSE-WEL2025-09-05
05060640673021OrdoSL-WGL2025-09-05

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
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
00073950319881Waterpik Aquarius Professional Water Flosser Dummy UnitWATER PIK, INC.EFS2026-01-12