Ensure Type 5 Steam Sterilization Integrator SCI-T5

GUDID 27540196001629

Type 5 Steam Sterilization Integrator

Scican Ltd

Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator Chemical/physical sterilization process indicator
Primary Device ID27540196001629
NIH Device Record Key7c96e9c9-06ec-4a52-aa66-22f83b0d39dd
Commercial Distribution StatusIn Commercial Distribution
Brand NameEnsure Type 5 Steam Sterilization Integrator
Version Model NumberSCI-T5
Catalog NumberSCI-T5
Company DUNS204137145
Company NameScican Ltd
Device Count100
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone18006677733
Emailtboyce@scican.com
Phone18006677733
Emailtboyce@scican.com
Phone18006677733
Emailtboyce@scican.com
Phone18006677733
Emailtboyce@scican.com
Phone18006677733
Emailtboyce@scican.com
Phone18006677733
Emailtboyce@scican.com
Phone18006677733
Emailtboyce@scican.com
Phone18006677733
Emailtboyce@scican.com
Phone18006677733
Emailtboyce@scican.com
Phone18006677733
Emailtboyce@scican.com
Phone18006677733
Emailtboyce@scican.com
Phone18006677733
Emailtboyce@scican.com
Phone18006677733
Emailtboyce@scican.com
Phone18006677733
Emailtboyce@scican.com
Phone18006677733
Emailtboyce@scican.com
Phone18006677733
Emailtboyce@scican.com
Phone18006677733
Emailtboyce@scican.com
Phone18006677733
Emailtboyce@scican.com

Device Identifiers

Device Issuing AgencyDevice ID
GS107540196001625 [Unit of Use]
GS117540196001622 [Primary]
GS127540196001629 [Package]
Contains: 17540196001622
Package: Carton [10 Units]
In Commercial Distribution

FDA Product Code

JOJIndicator, Physical/Chemical Sterilization Process

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-10-01
Device Publish Date2018-08-30

Devices Manufactured by Scican Ltd

07540196003179 - STATIM 5000 G4 Cassette Autoclave2023-07-04 Table-top steam sterilizer with removable extended cassette sterilization chamber
07540196003186 - STATIM 5000 G4 Cassette Autoclave2023-07-04 Table-top steam sterilizer with removable extended cassette sterilization chamber (Loaner)
07540196003193 - STATIM 5000 G4 Cassette Autoclave2023-07-04 Table-top steam sterilizer with removable extended cassette sterilization chamber (Refurbished)
07540196002097 - BRAVO 17V Autoclave2023-06-13 Table-top steam sterilizer (Refurbished)
07540196002103 - BRAVO 17V Autoclave2023-06-13 Table-top steam sterilizer (Loaner)
07540196002110 - BRAVO 17V Autoclave2023-06-13 Table-top steam sterilizer (Loaner)
17540196002353 - Statcare spray2023-06-13 One step, pre-sterilization handpiece maintenance spray
17540196002360 - Statmatic spray2023-06-13 One step, pre-sterilization handpiece maintenance spray

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