VaryFlex Taper Regular, VFTRSx, 19mm

GUDID 05060940370002

ENDOPERFECTION LIMITED

Rotary/reciprocating endodontic file/rasp, single-use

• Primary Device ID: 05060940370002
• NIH Device Record Key: f99bf37d-0573-45e3-bf64-03df183b7ad5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VaryFlex Taper Regular, VFTRSx, 19mm
• Version Model Number: VFTRSx
• Company DUNS: 224419290
• Company Name: ENDOPERFECTION LIMITED
• 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: 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	05060940370002 [Primary]

FDA Product Code

• EKS: File, Pulp Canal, Endodontic

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-12-21
• Device Publish Date: 2023-12-13

Devices Manufactured by ENDOPERFECTION LIMITED

• 05060940379418 - VaryFlex OR, VFOR, 20/07, 19mm: 2025-04-10
• 05060940376905 - VaryFlex Neo, 30/04, 25mm: 2024-04-12
• 05060940376912 - VaryFlex Neo, 35/04, 25mm: 2024-04-12
• 05060940376929 - VaryFlex Neo, 40/04, 25mm: 2024-04-12
• 05060940376936 - VaryFlex Neo, 50/04, 25mm: 2024-04-12
• 05060940376943 - VaryFlex Neo, 15/04, 31mm: 2024-04-12
• 05060940376950 - VaryFlex Neo, 25/04, 31mm: 2024-04-12
• 05060940376967 - VaryFlex Neo, 30/04, 31mm: 2024-04-12