EdgeOne-R Utopia R-Glide EORURG31S

GUDID 23701310322684

Endodontic instrument for professional dental use only

MICRO MEGA

Rotary/reciprocating endodontic file/rasp, single-use

• Primary Device ID: 23701310322684
• NIH Device Record Key: b10ba438-b261-44b5-91ae-cb7b8cbc9633
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EdgeOne-R Utopia R-Glide
• Version Model Number: L31 Sterile
• Catalog Number: EORURG31S
• Company DUNS: 276075371
• Company Name: MICRO MEGA
• Device Count: 1
• 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: 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	03701310322680 [Primary]
GS1	23701310322684 [Package]; Contains: 03701310322680; 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: 2024-04-16
• Device Publish Date: 2024-04-08

On-Brand Devices [EdgeOne-R Utopia R-Glide]

• 23701310322707: Endodontic instrument for professional dental use only
• 23701310322691: Endodontic instrument for professional dental use only
• 23701310322684: Endodontic instrument for professional dental use only