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

• Primary Device ID: 17540196000625
• NIH Device Record Key: 8f849c65-0aa6-4957-9776-1148c0f1bf9f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sterilization Monitors, Steam
• Version Model Number: SCI134-US
• Catalog Number: SCI134-US
• Company DUNS: 204137145
• Company Name: Scican Ltd
• Device Count: 250
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 18006677733
• Email: tboyce@scican.com
• Phone: 18006677733
• Email: tboyce@scican.com
• Phone: 18006677733
• Email: tboyce@scican.com
• Phone: 18006677733
• Email: tboyce@scican.com
• Phone: 18006677733
• Email: tboyce@scican.com
• Phone: 18006677733
• Email: tboyce@scican.com
• Phone: 18006677733
• Email: tboyce@scican.com
• Phone: 18006677733
• Email: tboyce@scican.com
• Phone: 18006677733
• Email: tboyce@scican.com
• Phone: 18006677733
• Email: tboyce@scican.com
• Phone: 18006677733
• Email: tboyce@scican.com
• Phone: 18006677733
• Email: tboyce@scican.com
• Phone: 18006677733
• Email: tboyce@scican.com
• Phone: 18006677733
• Email: tboyce@scican.com
• Phone: 18006677733
• Email: tboyce@scican.com
• Phone: 18006677733
• Email: tboyce@scican.com
• Phone: 18006677733
• Email: tboyce@scican.com
• Phone: 18006677733
• Email: tboyce@scican.com

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07540196000628 [Unit of Use]
GS1	17540196000625 [Primary]

FDA Product Code

• LRT: Indicator, Sterilization

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-08-02

Devices Manufactured by Scican Ltd

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• 07540196003193 - STATIM 5000 G4 Cassette Autoclave: 2023-07-04 Table-top steam sterilizer with removable extended cassette sterilization chamber (Refurbished)
• 07540196002097 - BRAVO 17V Autoclave: 2023-06-13 Table-top steam sterilizer (Refurbished)
• 07540196002103 - BRAVO 17V Autoclave: 2023-06-13 Table-top steam sterilizer (Loaner)
• 07540196002110 - BRAVO 17V Autoclave: 2023-06-13 Table-top steam sterilizer (Loaner)
• 17540196002353 - Statcare spray: 2023-06-13 One step, pre-sterilization handpiece maintenance spray
• 17540196002360 - Statmatic spray: 2023-06-13 One step, pre-sterilization handpiece maintenance spray