FlexiWheel

GUDID D77940305216

FlexiWheels Superfine Pink

COSMEDENT, INC.

Dental abrasive disk, single-use Dental abrasive disk, single-use Dental abrasive disk, single-use Dental abrasive disk, single-use Dental abrasive disk, single-use Dental abrasive disk, single-use Dental abrasive disk, single-use Dental abrasive disk, single-use Dental abrasive disk, single-use Dental abrasive disk, single-use Dental abrasive disk, single-use Dental abrasive disk, single-use Dental abrasive disk, single-use

• Primary Device ID: D77940305216
• NIH Device Record Key: fba47e97-dd93-4659-9808-ee6c69b44487
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FlexiWheel
• Version Model Number: 403502
• Company DUNS: 113911689
• Company Name: COSMEDENT, 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: true
• Lot Batch: false
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D77940305216 [Primary]

FDA Product Code

• EHJ: Disk, Abrasive

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: 2020-12-03
• Device Publish Date: 2020-11-25

On-Brand Devices [FlexiWheel]

• D77940305216: FlexiWheels Superfine Pink
• D77940305115: FlexiWheels Medium Blue
• D77940305014: FlexiWheel Starter Kit