Diamond Polish Mint 5541

GUDID 00883205104298

Diamond Polish Mint 1.0 Micron Refill

ULTRADENT PRODUCTS, INC.

Ertapenem susceptibility testing disc IVD

• Primary Device ID: 00883205104298
• NIH Device Record Key: ef3402a2-477c-4333-8575-68dacb542e48
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Diamond Polish Mint
• Version Model Number: 5541
• Catalog Number: 5541
• Company DUNS: 013369913
• Company Name: ULTRADENT PRODUCTS, INC.
• Device Count: 1
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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

Customer Support Contacts

• Phone: +1(801)572-4200
• Email: customerservice@ultradent.com

Device Dimensions

• Device Size Text, specify: 0

Operating and Storage Conditions

• Storage Environment Temperature: Between 18 Degrees Celsius and 29 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00883205104298 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K921407

FDA Product Code

• EBF: MATERIAL, TOOTH SHADE, RESIN

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-22

On-Brand Devices [Diamond Polish Mint]

• 00883205104304: Diamond Polish Mint 0.5 micron Refill
• 00883205104298: Diamond Polish Mint 1.0 Micron Refill