VersaLite

GUDID 00817051021003

VersaLite A3.5 prefilled tips, 20

CENTRIX, INC.

Dental composite resin

• Primary Device ID: 00817051021003
• NIH Device Record Key: e704219a-2832-438e-b5f2-683f2428c781
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VersaLite
• Version Model Number: 330602
• Company DUNS: 053707303
• Company Name: CENTRIX, 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817051021003 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K823510

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: 2016-09-23

On-Brand Devices [VersaLite]

• 00817051021058: VersaLite A3 prefilled tips, 20
• 00817051021041: VersaLite C3 prefilled tips, 20
• 00817051021034: VersaLite B3 prefilled tips, 20
• 00817051021027: VersaLite B2 prefilled tips, 20
• 00817051021010: VersaLite B1 prefilled tips, 20
• 00817051021003: VersaLite A3.5 prefilled tips, 20
• 00817051020990: VersaLite A2 prefilled tips, 20
• 00817051020983: VersaLite A1 prefilled tips, 20