FDA.reportPublic FDA data

Tonowash

Primary DI
00860012823505
Brand
Tonowash
Company
Eye-Novation LLC
Model
1.0
Device description
Device for automatically disinfecting tonometer tips
Published
2024-10-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
MECDisinfector, Medical Devices

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MECDisinfector, Medical DevicesGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860012823505PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860012823505008600128235058600128235050860012823505

GMDN Terms#

Term, Definition table
TermDefinition
Medical device disinfection solution containerAn empty receptacle designed to hold a disinfection solution for subsequent disinfection of a medical device (e.g., dental suction system, water pipeline); it is not intended to hold medical devices or to be used during a medical procedure. It is available in various forms (e.g., open jar, enclosed tank) and may include connection tubing and/or manual controls and valves to regulate the supply of the disinfectant to the medical equipment. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
079219839
Device count
1
Premarket exempt
true
Serial number
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08051520024108SteelcoSTEELCO SPAMEC2026-05-26
08051520022876SteelcoSTEELCO SPAMEC2026-04-17
08051520022852SteelcoSTEELCO SPAMEC2026-03-27
08051520022869SteelcoSTEELCO SPAMEC2026-02-04
04002516952589SteelcoMiele & Cie. KGMEC2026-01-04
04002516952749SteelcoMiele & Cie. KGMEC2026-01-04
04002516952848SteelcoMiele & Cie. KGMEC2026-01-04
04002516952947SteelcoMiele & Cie. KGMEC2026-01-04
08051520021176SteelcoSTEELCO SPAMEC2025-10-28
08051520021770SteelcoSTEELCO SPAMEC2025-09-24
08051520021763SteelcoSTEELCO SPAMEC2025-09-16
00848530020118CPAP CleanerSunset Healthcare Solutions, Inc.MEC2025-08-28
00848530096564CPAP CleanerSunset Healthcare Solutions, Inc.MEC2025-08-27
00848530020101CPAP CleaningSunset Healthcare Solutions, Inc.MEC2025-08-27
00848530080525Germicidal Deodorizing CleanserSunset Healthcare Solutions, Inc.MEC2025-08-27
00848530084813CPAP CleanerSunset Healthcare Solutions, Inc.MEC2025-08-27
00848530087067CPAP CleanerSunset Healthcare Solutions, Inc.MEC2025-08-27
08051520021473SteelcoSTEELCO SPAMEC2025-07-24
08051520021480SteelcoSTEELCO SPAMEC2025-07-24
07640397421250HYDRIM C61WD G4 Instrument Washer-DisinfectorDent4You AGMEC2025-07-22
07640397421267HYDRIM C61WD G4 Instrument Washer-DisinfectorDent4You AGMEC2025-07-22
07640397421274HYDRIM C61WD G4 Instrument Washer-DisinfectorDent4You AGMEC2025-07-22
07640397421281HYDRIM C61WD G4 Instrument Washer-DisinfectorDent4You AGMEC2025-07-22
04002516883838MieleMiele & Cie. KGMEC2025-07-01
04002516883845MieleMiele & Cie. KGMEC2025-07-01
04002516884781MieleMiele & Cie. KGMEC2025-07-01
04002516884927MieleMiele & Cie. KGMEC2025-07-01
04002516884934MieleMiele & Cie. KGMEC2025-07-01
08051520020957SteelcoSTEELCO SPAMEC2025-06-30
08051520021350SteelcoSTEELCO SPAMEC2025-06-18