SporView® Self-contained Biological Indicator

GUDID 00732224721521

SCBI 10^6 STEAM, 25/BX

CROSSTEX INTERNATIONAL, INC.

Biological sterilization indicator Biological sterilization indicator Biological sterilization indicator Biological sterilization indicator Biological sterilization indicator Biological sterilization indicator Biological sterilization indicator Biological sterilization indicator Biological sterilization indicator Biological sterilization indicator Biological sterilization indicator Biological sterilization indicator Biological sterilization indicator Biological sterilization indicator Biological sterilization indicator Biological sterilization indicator Biological sterilization indicator Biological sterilization indicator Biological sterilization indicator

• Primary Device ID: 00732224721521
• NIH Device Record Key: e3c2cacf-13d5-44b5-80bb-6675f3709e30
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SporView® Self-contained Biological Indicator
• Version Model Number: SCS-026-I
• Company DUNS: 057728685
• Company Name: CROSSTEX INTERNATIONAL, INC.
• Device Count: 25
• DM Exempt: true
• 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: true

Customer Support Contacts

• Phone: +1(585)359-0130
• Email: info@spsmedical.com
• Phone: +1(585)359-0130
• Email: info@spsmedical.com
• Phone: +1(585)359-0130
• Email: info@spsmedical.com
• Phone: +1(585)359-0130
• Email: info@spsmedical.com
• Phone: +1(585)359-0130
• Email: info@spsmedical.com
• Phone: +1(585)359-0130
• Email: info@spsmedical.com
• Phone: +1(585)359-0130
• Email: info@spsmedical.com
• Phone: +1(585)359-0130
• Email: info@spsmedical.com
• Phone: +1(585)359-0130
• Email: info@spsmedical.com
• Phone: +1(585)359-0130
• Email: info@spsmedical.com
• Phone: +1(585)359-0130
• Email: info@spsmedical.com
• Phone: +1(585)359-0130
• Email: info@spsmedical.com
• Phone: +1(585)359-0130
• Email: info@spsmedical.com
• Phone: +1(585)359-0130
• Email: info@spsmedical.com
• Phone: +1(585)359-0130
• Email: info@spsmedical.com
• Phone: +1(585)359-0130
• Email: info@spsmedical.com
• Phone: +1(585)359-0130
• Email: info@spsmedical.com
• Phone: +1(585)359-0130
• Email: info@spsmedical.com
• Phone: +1(585)359-0130
• Email: info@spsmedical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00732224721521 [Unit of Use]
GS1	10732224721528 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111515

FDA Product Code

• FRC: Indicator, biological sterilization process

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-04-08
• Device Publish Date: 2020-03-31

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