Ensure Sterilization Pouch SCI-SCP

GUDID 27540196001650

Self-sealing sterilization pouches with internal and external multi-variable (parameter) chemical indicator

Scican Ltd

Sterilization packaging, single-use

• Primary Device ID: 27540196001650
• NIH Device Record Key: 7ed042d6-6a7b-4593-aa34-625884b0c50f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ensure Sterilization Pouch
• Version Model Number: SCI-SCP
• Catalog Number: SCI-SCP
• Company DUNS: 204137145
• Company Name: Scican Ltd
• Device Count: 200
• 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
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07540196001656 [Unit of Use]
GS1	17540196001653 [Primary]
GS1	27540196001650 [Package]; Contains: 17540196001653; Package: Carton [20 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K941327

FDA Product Code

• KCT: Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

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: 2019-11-08
• Device Publish Date: 2018-08-30

Devices Manufactured by Scican Ltd

• 07540196003179 - STATIM 5000 G4 Cassette Autoclave: 2023-07-04 Table-top steam sterilizer with removable extended cassette sterilization chamber
• 07540196003186 - STATIM 5000 G4 Cassette Autoclave: 2023-07-04 Table-top steam sterilizer with removable extended cassette sterilization chamber (Loaner)
• 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