EVO FLEX 60040191

GUDID J015600401919

Endodontic instrument for professionnal dental use only

MICRO MEGA

Rotary/reciprocating endodontic file/rasp, single-use

• Primary Device ID: J015600401919
• NIH Device Record Key: ac4596e3-8eee-4b93-a9e9-b00ee1a37ed5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EVO FLEX
• Version Model Number: N14 3% L25 Sterile
• Catalog Number: 60040191
• Company DUNS: 276075371
• Company Name: MICRO MEGA
• Device Count: 6
• DM Exempt: true
• 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: true
• 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

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight
• Special Storage Condition, Specify: Between 0 and 0 *Keep dry
• Special Storage Condition, Specify: Between 0 and 0 *Keep away from sunlight

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	J015600401910 [Unit of Use]
HIBCC	J015600401911 [Primary]
HIBCC	J015600401919 [Package]; Contains: J015600401911; Package: [10 Units]; In Commercial Distribution

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: 2025-03-03
• Device Publish Date: 2025-02-21

On-Brand Devices [EVO FLEX]

• J015600402049: Endodontic instrument for professionnal dental use only
• J015600402039: Endodontic instrument for professionnal dental use only
• J015600402029: Endodontic instrument for professionnal dental use only
• J015600402019: Endodontic instrument for professionnal dental use only
• J015600402009: Endodontic instrument for professionnal dental use only
• J015600401999: Endodontic instrument for professionnal dental use only
• J015600401989: Endodontic instrument for professionnal dental use only
• J015600401979: Endodontic instrument for professionnal dental use only
• J015600401969: Endodontic instrument for professionnal dental use only
• J015600401959: Endodontic instrument for professionnal dental use only
• J015600401949: Endodontic instrument for professionnal dental use only
• J015600401939: Endodontic instrument for professionnal dental use only
• J015600401929: Endodontic instrument for professionnal dental use only
• J015600401919: Endodontic instrument for professionnal dental use only
• J015600401900: Endodontic instrument for professionnal dental use only