TheraCem Ca D-46502PS

GUDID D757D46502PS0

THERACEM Ca 1g DUAL SYR SMPL PKG

BISCO INC.

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• Primary Device ID: D757D46502PS0
• NIH Device Record Key: 49f9650d-1421-4dec-95d8-edbac98b1e1a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TheraCem Ca
• Version Model Number: D-46502PS
• Catalog Number: D-46502PS
• Company DUNS: 053529939
• Company Name: BISCO INC.
• Device Count: 1
• 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: false
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 847-534-6000
• Email: sales@bisco.com
• Phone: 847-534-6000
• Email: sales@bisco.com
• Phone: 847-534-6000
• Email: sales@bisco.com
• Phone: 847-534-6000
• Email: sales@bisco.com
• Phone: 847-534-6000
• Email: sales@bisco.com
• Phone: 847-534-6000
• Email: sales@bisco.com
• Phone: 847-534-6000
• Email: sales@bisco.com
• Phone: 847-534-6000
• Email: sales@bisco.com
• Phone: 847-534-6000
• Email: sales@bisco.com
• Phone: 847-534-6000
• Email: sales@bisco.com
• Phone: 847-534-6000
• Email: sales@bisco.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius
• Storage Environment Temperature: Between 20 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D757D46502PS0 [Primary]

FDA Product Code

• EID: Syringe, Restorative And Impression Material

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-05-10
• Device Publish Date: 2018-03-02

On-Brand Devices [TheraCem Ca]

• D757D46502S0: THERACEM Ca 1G DUAL SYR SAMPLE
• D757D46502PS0: THERACEM Ca 1g DUAL SYR SMPL PKG
• D757D465010: THERACEM Ca 8g DUAL SYRINGE
• 00810111541312: THERACEM Ca 8g REFILL PACKAGE
• 00810111541336: THERACEM Ca 1g DUAL SYR SMPL PKG
• 00810111541305: THERACEM Ca 8g DUAL SYRINGE