FDA.reportPublic FDA data

Ensure Type 5 Steam Sterilization Integrator

Primary DI
17540196001622
Brand
Ensure Type 5 Steam Sterilization Integrator
Company
Scican Ltd
Model
SCI-T5
Catalog number
SCI-T5
Device description
Type 5 Steam Sterilization Integrator
Published
2018-08-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JOJIndicator, Physical/Chemical Sterilization Process

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JOJIndicator, Physical/Chemical Sterilization ProcessGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
27540196001629PackageGS110In Commercial Distribution
17540196001622PrimaryGS10
07540196001625Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2754019600162927540196001629
1754019600162217540196001622
07540196001625075401960016257540196001625

GMDN Terms#

Term, Definition table
TermDefinition
Chemical/physical sterilization process indicatorA sterilization indicator designed to be placed within a sterilizing chamber, and to respond with a characteristic chemical and/or physical change (non-electrical) to one or more of the physical conditions within the chamber, to validate the sterilization process. It may be presented in one of a variety of forms (e.g., tape, test pack, tag). This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
18006677733tboyce@scican.com

Regulatory Flags#

DUNS number
204137145
Device count
100
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07540196000017HYDRIM L110W G4 Instrument WasherL110W-D01-G4L110W-D01-G42016-08-02
07540196000024HYDRIM L110W G4 Instrument WasherL110W-D01-G4-RL110W-D01-G4-R2016-08-02
07540196000031HYDRIM L110W Instrument WasherL110W-D01-RL110W-D01-R2016-08-02
07540196000048HYDRIM C51W Instrument WasherC51W-D01-RC51W-D01-R2016-08-02
07540196000642HYDRIM C61W G4 Instrument WasherC61W-D01C61W-D012016-08-02
07540196000666HYDRIM C61WD G4 Instrument Washer-DisinfectorC61WD-D01C61WD-D012016-08-02
07540196000673HYDRIM C61WD G4 Instrument Washer-DisinfectorC61WD-D01-LCSC61WD-D01-LCS2016-08-02
07540196000680HYDRIM L110W G4 Instrument WasherL110W-D01SH-G4L110W-D01SH-G42018-09-07
07540196000994HYDRIM L110W G4 Instrument WasherL110W-D01-G4-LL110W-D01-G4-L2018-01-17
07540196001007HYDRIM L110W Instrument WasherL110W-D01-LL110W-D01-L2018-01-17
07540196001236HYDRIM C51W Instrument WasherC51W-D01-LC51W-D01-L2018-01-17
07540196001250HYDRIM C61W G4 Instrument WasherC61W-D01-LC61W-D01-L2018-01-17
07540196001267HYDRIM C61WD G4 Instrument Washer-DisinfectorC61WD-D01-LC61WD-D01-L2018-01-17
07540196001274HYDRIM C61WD G4 Instrument Washer-DisinfectorC61WD-D01-RC61WD-D01-R2018-01-17
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

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