Sterilization Monitors, Steam SCI134-US

GUDID 17540196000625

Chemical indicator strips designed for use in steam sterilizers operating at 132°C to 135°C (270°F to 276°F) to give a visible indication that sterili

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 ID17540196000625
NIH Device Record Key8f849c65-0aa6-4957-9776-1148c0f1bf9f
Commercial Distribution StatusIn Commercial Distribution
Brand NameSterilization Monitors, Steam
Version Model NumberSCI134-US
Catalog NumberSCI134-US
Company DUNS204137145
Company NameScican Ltd
Device Count250
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

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store at normal room temperature 50°-100°F (10-38°C) and 10-70% R.H.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at normal room temperature 50°-100°F (10-38°C) and 10-70% R.H.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at normal room temperature 50°-100°F (10-38°C) and 10-70% R.H.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at normal room temperature 50°-100°F (10-38°C) and 10-70% R.H.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at normal room temperature 50°-100°F (10-38°C) and 10-70% R.H.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at normal room temperature 50°-100°F (10-38°C) and 10-70% R.H.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at normal room temperature 50°-100°F (10-38°C) and 10-70% R.H.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at normal room temperature 50°-100°F (10-38°C) and 10-70% R.H.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at normal room temperature 50°-100°F (10-38°C) and 10-70% R.H.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at normal room temperature 50°-100°F (10-38°C) and 10-70% R.H.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at normal room temperature 50°-100°F (10-38°C) and 10-70% R.H.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at normal room temperature 50°-100°F (10-38°C) and 10-70% R.H.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at normal room temperature 50°-100°F (10-38°C) and 10-70% R.H.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at normal room temperature 50°-100°F (10-38°C) and 10-70% R.H.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at normal room temperature 50°-100°F (10-38°C) and 10-70% R.H.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at normal room temperature 50°-100°F (10-38°C) and 10-70% R.H.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at normal room temperature 50°-100°F (10-38°C) and 10-70% R.H.
Special Storage Condition, SpecifyBetween 0 and 0 *Store at normal room temperature 50°-100°F (10-38°C) and 10-70% R.H.

Device Identifiers

Device Issuing AgencyDevice ID
GS107540196000628 [Unit of Use]
GS117540196000625 [Primary]

FDA Product Code

LRTIndicator, Sterilization

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-08-02

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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