BlueCheck

GUDID 09359621000014

BlueCheck Caries Detection & Monitoring Medical Device Dental 0.3 mL x 10

INCISIVE TECHNOLOGIES PTY LTD

Dental caries detecting stain

• Primary Device ID: 09359621000014
• NIH Device Record Key: 24dc5cfc-3388-48e7-9050-2966fb60efbd
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BlueCheck
• Version Model Number: BN01BUS
• Company DUNS: 747210755
• Company Name: INCISIVE TECHNOLOGIES PTY LTD
• Device Count: 10
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	09359621000014 [Unit of Use]
GS1	09359621000038 [Primary]
GS1	19359621000035 [Package]; Contains: 09359621000038; Package: Shipper [140 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222560

FDA Product Code

• LFC: Device, Caries Detection

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: 2024-11-28
• Device Publish Date: 2024-11-20

On-Brand Devices [BlueCheck]

• 09359621000014: BlueCheck Caries Detection & Monitoring Medical Device Dental 0.3 mL x 10
• 09359621000021: BlueCheck Caries Detection & Monitoring Medical Device Dental 0.3 mL x 1