Monolith Prophy Powder Genie Smile SOFT PERIO

GUDID 04064896000489

PRISMAN INC.

Dental abrasive powder

• Primary Device ID: 04064896000489
• NIH Device Record Key: dc3ecdce-69dc-46e1-ba72-4ccad679cf57
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Monolith Prophy Powder Genie Smile SOFT PERIO
• Version Model Number: M518
• Company DUNS: 117569946
• Company Name: PRISMAN 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: 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04064896000489 [Primary]

FDA Product Code

• EJR: Agent, Polishing, Abrasive, Oral Cavity

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: 2021-10-18
• Device Publish Date: 2021-10-10

On-Brand Devices [Monolith Prophy Powder Genie Smile SOFT PERIO]

• 04064896000496: M519
• 04064896000489: M518