ZirClean B-7351P

GUDID 00810111542487

ZIRCLEAN - 5 gram SYRINGE Pkg

BISCO INC.

Dental restoration fixation cleaning solution

• Primary Device ID: 00810111542487
• NIH Device Record Key: a3e4114f-2efd-4d85-84a9-f9d4e47526ce
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ZirClean
• Version Model Number: B-7351P
• Catalog Number: B-7351P
• 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: true
• 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: +1(847) 534-6000
• Email: sales@bisco.com
• Phone: +1(847) 534-6000
• Email: sales@bisco.com
• Phone: +1(847) 534-6000
• Email: sales@bisco.com
• Phone: +1(847) 534-6000
• Email: sales@bisco.com
• Phone: +1(847) 534-6000
• Email: sales@bisco.com
• Phone: +1(847) 534-6000
• Email: sales@bisco.com
• Phone: +1(847) 534-6000
• Email: sales@bisco.com
• Phone: +1(847) 534-6000
• Email: sales@bisco.com
• Phone: +1(847) 534-6000
• Email: sales@bisco.com
• Phone: +1(847) 534-6000
• Email: sales@bisco.com
• Phone: +1(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
GS1	00810111542487 [Primary]
HIBCC	D757B7351P1 [Previous]

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-08-08
• Device Publish Date: 2022-07-29

On-Brand Devices [ZirClean]

• D757B7351P1: ZIRCLEAN - 5 gram SYRINGE Pkg
• D757B73510: ZIRCLEAN - 5 gram SYRINGE
• 00810111542487: ZIRCLEAN - 5 gram SYRINGE Pkg
• 00810111542470: ZIRCLEAN - 5 gram SYRINGE