COMO Black

GUDID 08800019110712

B& L Biotech, inc.

Dental material application tool, reusable

• Primary Device ID: 08800019110712
• NIH Device Record Key: 80e60725-50ad-475f-b560-8e4c93dce7fa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: COMO Black
• Version Model Number: COMB
• Company DUNS: 687338285
• Company Name: B& L Biotech, inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800019110712 [Primary]

FDA Product Code

• KXR: Applicator, Resin

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: 2023-06-23
• Device Publish Date: 2023-06-15

Devices Manufactured by B& L Biotech, inc.

• 08800019115038 - B&L Mirror: 2024-12-27
• 08800019151319 - DS Tip: 2024-12-13
• 08800019151326 - DS Tip: 2024-12-13
• 08800019151333 - DS Tip: 2024-12-13
• 08800019151340 - DS Tip: 2024-12-13
• 08800019151357 - DS Tip: 2024-12-13
• 08800019151364 - DS Tip: 2024-12-13
• 08800019151371 - DS Tip: 2024-12-13