FDA.reportPublic FDA data

HYDRIM C61W G4 Instrument Washer

Primary DI
07540196001250
Brand
HYDRIM C61W G4 Instrument Washer
Company
Scican Ltd
Model
C61W-D01-L
Catalog number
C61W-D01-L
Device description
Automated instrument washer (Loaner)
Published
2018-01-17
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
LDSDevice, Pasteurization, Hot Water

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LDSDevice, Pasteurization, Hot WaterGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07540196001250PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07540196001250075401960012507540196001250

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

Contacts#

Phone, Email table
PhoneEmail
18006677733tboyce@scican.com

Regulatory Flags#

DUNS number
204137145
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
07540196001786STATCLAVE G4 Chamber AutoclaveG4-621103G4-6211032019-08-13
07540196003803STATCLAVE G4 Chamber AutoclaveG4-621103-RG4-621103-R2022-04-07
07540196003810STATCLAVE G4 Chamber AutoclaveG4-621103-LG4-621103-L2022-04-07
07540196001793STATCLAVE G4 Chamber AutoclaveG4-622303G4-6223032021-08-18
07540196003179STATIM 5000 G4 Cassette AutoclaveG4-211103G4-2111032023-06-26
07540196003186STATIM 5000 G4 Cassette AutoclaveG4-211103-LG4-211103-L2023-06-26
07540196003193STATIM 5000 G4 Cassette AutoclaveG4-211103-RG4-211103-R2023-06-26
07540196002455BRAVO G4 Chamber Autoclave7A6200307A6200302022-11-18
07540196002462BRAVO G4 Chamber Autoclave7A6210307A6210302022-11-18
07540196002479BRAVO G4 Chamber Autoclave7A6200107A6200102022-11-18
07540196002486BRAVO G4 Chamber Autoclave7A6210107A6210102022-11-18
07540196000420STATIM 5000 G4 Cassette AutoclaveG4-201103G4-2011032016-08-02
07540196000437STATIM 5000 G4 Cassette AutoclaveG4-201103-LG4-201103-L2016-08-02
07540196000444STATIM 5000 G4 Cassette AutoclaveG4-201103-RG4-201103-R2016-08-02
07540196000451STATIM 2000 G4 Cassette AutoclaveG4-121101G4-1211012016-08-02
07540196000475STATIM 2000 G4 Cassette AutoclaveG4-121101-RG4-121101-R2016-08-02
07540196000642HYDRIM C61W G4 Instrument WasherC61W-D01C61W-D012016-08-02
07540196000666HYDRIM C61WD G4 Instrument Washer-Disinfector C61WD-D01C61WD-D012016-08-02
07540196000673HYDRIM C61WD G4 Instrument Washer-Disinfector C61WD-D01-LCS C61WD-D01-LCS 2016-08-02
07540196001267HYDRIM C61WD G4 Instrument Washer-Disinfector C61WD-D01-LC61WD-D01-L2018-01-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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07640397422332HIP Cleaning SolutionDent4You AGLDS2026-02-11
07640397422189HYDRIM 112W G4+ Instrument WasherDent4You AGLDS2026-02-11
17640397422339HIP Cleaning SolutionDent4You AGLDS2026-02-11
07640397422349HYDRIM 112W G4+ Instrument WasherDent4You AGLDS2026-02-11
07640397422356HYDRIM 112W G4+ Instrument WasherDent4You AGLDS2026-02-11
E308210050010Talos+ RIW-100TTW & H STERILIZATION SRLLDS2025-12-23
E308210060010Talos+ RIW-100UCW & H STERILIZATION SRLLDS2025-12-23
07640397421885HYDRIM C61W G4 Instrument WasherDent4You AGLDS2025-01-15
07640397421892HYDRIM C61W G4 Instrument WasherDent4You AGLDS2025-01-15
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07640397421939HYDRIM L110W G4 Instrument WasherDent4You AGLDS2025-01-15
07640397421946HYDRIM L110W G4 Instrument WasherDent4You AGLDS2025-01-15
07640397421953HYDRIM L110W G4 Instrument WasherDent4You AGLDS2025-01-15
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07290110640880TIVA10-1V-HS-MDTUTTNAUER ISRAEL LTD.LDS2023-06-20
07290110640897TIVA10-2V-HS-MDTUTTNAUER ISRAEL LTD.LDS2023-06-20
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07540196001076HIPScican LtdLDS2020-11-09
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07540196001090HIPScican LtdLDS2020-11-09
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