ProFlare

GUDID 00348783001181

ProFlare Articulating DPA (Bag of 125)

PREMIER DENTAL PRODUCTS COMPANY

Dentifrice Dentifrice Dentifrice Dentifrice Dentifrice Dentifrice Dentifrice Dentifrice Dentifrice Dentifrice Dentifrice Dentifrice Dentifrice Dentifrice Dentifrice Dentifrice Dentifrice Dentifrice

• Primary Device ID: 00348783001181
• NIH Device Record Key: d71fc6f3-be72-4845-8692-87b3ebfda180
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ProFlare
• Version Model Number: 5500150
• Company DUNS: 014789663
• Company Name: PREMIER DENTAL PRODUCTS COMPANY
• 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: true
• Serial Number: false
• Manufacturing Date: true
• 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
GS1	00348783001181 [Primary]
GS1	00348783001198 [Package]; Package: Case [10 Units]; In Commercial Distribution

FDA Product Code

• EHK: Cup, Prophylaxis

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: 2023-11-03
• Device Publish Date: 2023-10-26

On-Brand Devices [ProFlare]

• 00348783004564: ProFlare Articulating Disposable Prophy Angle Sample
• 00348783001181: ProFlare Articulating DPA (Bag of 125)