Opaquer B-2122

GUDID D757B21220

Opaquer Base 3ml Bottle

BISCO INC.

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• Primary Device ID: D757B21220
• NIH Device Record Key: 78c1e64f-b339-42ce-b806-ab468d3ee4fd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Opaquer
• Version Model Number: B-2122
• Catalog Number: B-2122
• 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: +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
• 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
• 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
• 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
• 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	D757B21220 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K874557

FDA Product Code

• EBC: SEALANT, PIT AND FISSURE, AND CONDITIONER

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2022-06-02
• Device Publish Date: 2017-06-12

On-Brand Devices [Opaquer]

• D757B2122Q1: Opaquer Base 3ml Bottle Pkg
• D757B21220: Opaquer Base 3ml Bottle
• D757B2112Q1: Opaquer Catalyst 3ml Bottle Pkg
• D757B21120: Opaquer Catalyst 3ml Bottle
• 00810111542425: Opaquer Base 3ml Bottle
• 10810111542415: Opaquer Catalyst 3ml Bottle