Topex® AD32013

GUDID D687AD320130

Topex® Dual Arch Tray Large Bag of 50

Sultan Healthcare Inc

Fluoride gel tray Fluoride gel tray Fluoride gel tray Fluoride gel tray Fluoride gel tray Fluoride gel tray Fluoride gel tray Fluoride gel tray Fluoride gel tray Fluoride gel tray Fluoride gel tray Fluoride gel tray Fluoride gel tray Fluoride gel tray Fluoride gel tray

• Primary Device ID: D687AD320130
• NIH Device Record Key: 3c6eccd9-48d2-45ff-994a-ad078547e7a6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Topex®
• Version Model Number: AD32010
• Catalog Number: AD32013
• 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	D687AD320130 [Unit of Use]
HIBCC	D687AD320131 [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: 2022-12-12
• Device Publish Date: 2022-12-03

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