SteriTec Self-Contained BI Steam Box

GUDID 00732224757476

Self-Contained BI Steam Box

SPS Medical Supply Corp.

Biological sterilization indicator

• Primary Device ID: 00732224757476
• NIH Device Record Key: bb29308d-9b8c-46fc-b8c4-27f96e583e62
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SteriTec Self-Contained BI Steam Box
• Version Model Number: BI-038
• Company DUNS: 194877072
• Company Name: SPS Medical Supply Corp.
• Device Count: 100
• 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(631)633-6201
• Email: rcelestin@crosstex.com
• Phone: +1(631)633-6201
• Email: rcelestin@crosstex.com
• Phone: +1(631)633-6201
• Email: rcelestin@crosstex.com
• Phone: +1(631)633-6201
• Email: rcelestin@crosstex.com
• Phone: +1(631)633-6201
• Email: rcelestin@crosstex.com
• Phone: +1(631)633-6201
• Email: rcelestin@crosstex.com
• Phone: +1(631)633-6201
• Email: rcelestin@crosstex.com
• Phone: +1(631)633-6201
• Email: rcelestin@crosstex.com
• Phone: +1(631)633-6201
• Email: rcelestin@crosstex.com
• Phone: +1(631)633-6201
• Email: rcelestin@crosstex.com
• Phone: +1(631)633-6201
• Email: rcelestin@crosstex.com
• Phone: +1(631)633-6201
• Email: rcelestin@crosstex.com
• Phone: +1(631)633-6201
• Email: rcelestin@crosstex.com
• Phone: +1(631)633-6201
• Email: rcelestin@crosstex.com
• Phone: +1(631)633-6201
• Email: rcelestin@crosstex.com
• Phone: +1(631)633-6201
• Email: rcelestin@crosstex.com
• Phone: +1(631)633-6201
• Email: rcelestin@crosstex.com
• Phone: +1(631)633-6201
• Email: rcelestin@crosstex.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *TRUE
• Special Storage Condition, Specify: Between 0 and 0 *TRUE
• Special Storage Condition, Specify: Between 0 and 0 *TRUE
• Special Storage Condition, Specify: Between 0 and 0 *TRUE
• Special Storage Condition, Specify: Between 0 and 0 *TRUE
• Special Storage Condition, Specify: Between 0 and 0 *TRUE
• Special Storage Condition, Specify: Between 0 and 0 *TRUE
• Special Storage Condition, Specify: Between 0 and 0 *TRUE
• Special Storage Condition, Specify: Between 0 and 0 *TRUE
• Special Storage Condition, Specify: Between 0 and 0 *TRUE
• Special Storage Condition, Specify: Between 0 and 0 *TRUE
• Special Storage Condition, Specify: Between 0 and 0 *TRUE
• Special Storage Condition, Specify: Between 0 and 0 *TRUE
• Special Storage Condition, Specify: Between 0 and 0 *TRUE
• Special Storage Condition, Specify: Between 0 and 0 *TRUE
• Special Storage Condition, Specify: Between 0 and 0 *TRUE
• Special Storage Condition, Specify: Between 0 and 0 *TRUE
• Special Storage Condition, Specify: Between 0 and 0 *TRUE

Device Identifiers

Device Issuing Agency	Device ID
GS1	00732224757476 [Unit of Use]
GS1	10732224757473 [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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-06-26
• Device Publish Date: 2020-11-18

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