Topex® AD32012

GUDID D687AD320120

Topex® Dual Arch Tray Medium Bag of 50

Sultan Healthcare Inc

Fluoride gel tray

• Primary Device ID: D687AD320120
• NIH Device Record Key: 4e17cce9-9597-4f11-9298-be7083c11f42
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Topex®
• Version Model Number: AD32012
• Catalog Number: AD32012
• Company DUNS: 056296981
• Company Name: Sultan Healthcare Inc
• Device Count: 50
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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
HIBCC	D687AD320120 [Unit of Use]
HIBCC	D687AD320121 [Primary]

FDA Product Code

• KMT: TRAY, FLUORIDE, DISPOSABLE

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: 2022-12-13
• Device Publish Date: 2022-12-05

On-Brand Devices [Topex® ]

• D687AD321030: Topex® Single Arch Tray Large Bag of 100
• D687AD321020: Topex® Single Arch Trays Medium Bag of 100
• D687AD321010: Topex® Single Arch Tray Small Bag of 100
• D687AD320130: Topex® Dual Arch Tray Large Bag of 50
• D687AD320110: Topex® Dual Arch Tray Small Bag of 50
• D687AD320100: Topex® Dual Arch Tray Pedo Bag of 50
• D687AD320120: Topex® Dual Arch Tray Medium Bag of 50