VersaFlo

GUDID 00817051020976

VersaFlo B1 2g syringe, 1

CENTRIX, INC.

Dental composite resin

• Primary Device ID: 00817051020976
• NIH Device Record Key: d37edbb0-1515-4336-a0e8-e26fe9b2eaca
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VersaFlo
• Version Model Number: 330538
• 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: false
• 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	00817051020976 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K960667

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 [VersaFlo]

• 00817051020976: VersaFlo B1 2g syringe, 1
• 00817051020969: VersaFlo A3.5 2g syringe, 1
• 00817051020952: VersaFlo A3 2g syringe, 1
• 00817051020945: VersaFlo A2 2g syringe, 1
• 00817051020938: VersaFlo A1 2g syringe, 1
• 00817051020921: VersaFlo B1 2g syringe, 6 pk
• 00817051020914: VersaFlo A3.5 2g syringe, 6 pk
• 00817051020907: VersaFlo A3 2g syringe, 6 pk
• 00817051020891: VersaFlo A2 2g syringe, 6 pk
• 00817051020884: VersaFlo A1 2g syringe, 6 pk
• 00817051020877: VersaFlo B1 prefilled NeedleTube, 16 pk
• 00817051020860: VersaFlo A3.5 prefilled NeedleTube, 16 pack
• 00817051020853: VersaFlo A3 prefilled NeedleTube, 16 pk
• 00817051020846: VersaFlo A2 prefilled NeedleTube, 16 pk
• 00817051020839: VersaFlo A1 prefilled NeedleTube, 16 pk