FDA.reportPublic FDA data

Steelco

Primary DI
08058341870525
Brand
Steelco
Company
STEELCO SPA
Model
DS 610/2 2S
Catalog number
DS 610/2 2S
Device description
This device is an under counter washer disinfector designed for the cleaning, thermal disinfection (intermediate level) and forced hot air drying of instruments used in surgeries, dental instruments and laboratory glassware.
Published
2019-11-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
08058341870525PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08058341870525080583418705258058341870525

GMDN Terms#

Term, Definition table
TermDefinition
Surgical utensil washer/disinfectorA mains electricity (AC-powered) unit designed to wash (remove dirt/stains), decontaminate (remove organic debris), and disinfect (destroy microorganisms) reusable surgical instruments, bowls, anaesthesia equipment components, and some surgical footwear. Most instruments, especially those used invasively or in a sterile field will require sterilization after this process. It is typically located in rooms and central supply departments designed to handle soiled instruments/utensils. It typically includes internal baskets/racks in which the utensils are placed to ensure circulation of the heated water/detergents to all surfaces.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
428717469
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08051520024108SteelcoTW 3000/2TW 3000/22026-05-26
08051520022876SteelcoDS 1000 2SDS 1000 2S2026-04-17
08051520022852SteelcoDS 1000 2SDS 1000 2S2026-03-27
08051520022869SteelcoDS 1000 2SDS 1000 2S2026-02-04
08051520021176SteelcoDS 1000 2SDS 1000 2S2025-10-28
08051520021770SteelcoLC 80/3LC 80/32025-09-24
08051520021763SteelcoLC 80/2LC 80/22025-09-16
08051520011337SteelcoED 100/1ED 100/1 2025-07-24
08051520021473SteelcoTW 3000/2TW 3000/22025-07-24
08051520021480SteelcoLC 80/2LC 80/22025-07-24
08051520020957SteelcoDS 1000 2SDS 1000 2S2025-06-30
08051520021350SteelcoDS 1000 1SDS 1000 1S2025-06-18
08051520021145SteelcoID 300/1ID 300/12025-05-22
08051520021190SteelcoDS 1000 N1SDS 1000 N1S2025-05-22
08051520021169SteelcoDS 1000 2SDS 1000 2S2025-05-08
08051520020940SteelcoDS 1000 2SDS 1000 2S2025-05-05
08051520021022SteelcoAD 400/2AD 400/22025-04-22
08051520020797SteelcoDS 1000 NDS 1000 N2025-04-10
08051520020667SteelcoAD 400/2AD 400/22025-03-24
08051520020636SteelcoBP 100 HSEBP 100 HSE2025-03-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08051520024108SteelcoSTEELCO SPAMEC2026-05-26
10841736125257Sterling WashersSKYTRON LLCMEC2026-04-26
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
10841736125141CleanStartSKYTRON LLCMEC2025-12-19
10841736125158CleanStartSKYTRON LLCMEC2025-12-19
10841736125165CleanStartSKYTRON LLCMEC2025-12-19
10841736125172CleanStartSKYTRON LLCMEC2025-12-19
10841736125189CleanStartSKYTRON LLCMEC2025-12-19
10841736125196CleanStartSKYTRON LLCMEC2025-12-19
10841736125202CleanStartSKYTRON LLCMEC2025-12-19
10841736125219CleanStartSKYTRON LLCMEC2025-12-19
10724995220614VERIFYALBERT BROWNE LIMITEDMEC2025-12-17
00724995220617VERIFYALBERT BROWNE LIMITEDMEC2025-12-17
10841736124427Sterling SKYTRON LLCMEC2025-12-09
10841736124434Sterling SKYTRON LLCMEC2025-12-09
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 Cleaning SUNSET HEALTHCARE SOLUTIONS, INC.MEC2025-08-27
00848530080525 Germicidal Deodorizing CleanserSUNSET HEALTHCARE SOLUTIONS, INC.MEC2025-08-27
00848530084813CPAP CleanerSUNSET HEALTHCARE SOLUTIONS, INC.MEC2025-08-27
00848530087067CPAP CleanerSUNSET HEALTHCARE SOLUTIONS, INC.MEC2025-08-27