EdgeOne-R Utopia EORUA21Sv2

GUDID 23701310322769

Endodontic instrument for professional dental use only

MICRO MEGA

Rotary/reciprocating endodontic file/rasp, single-use Rotary/reciprocating endodontic file/rasp, single-use Rotary/reciprocating endodontic file/rasp, single-use Rotary/reciprocating endodontic file/rasp, single-use Rotary/reciprocating endodontic file/rasp, single-use Rotary/reciprocating endodontic file/rasp, single-use Rotary/reciprocating endodontic file/rasp, single-use

• Primary Device ID: 23701310322769
• NIH Device Record Key: 86ed8b2f-8b3f-41a1-a9b6-2f340ec6dbfc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EdgeOne-R Utopia
• Version Model Number: Asst v2 L21 Sterile
• Catalog Number: EORUA21Sv2
• 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	03701310322765 [Primary]
GS1	23701310322769 [Package]; Contains: 03701310322765; 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]

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• 23701310370333: Endodontic instrument for professional dental use only
• 23701310370326: Endodontic instrument for professional dental use only
• 23701310370319: Endodontic instrument for professional dental use only
• 23701310370302: Endodontic instrument for professional dental use only
• 23701310370296: Endodontic instrument for professional dental use only
• 23701310370289: Endodontic instrument for professional dental use only
• 23701310370272: Endodontic instrument for professional dental use only
• 23701310370265: Endodontic instrument for professional dental use only
• 23701310370258: Endodontic instrument for professional dental use only
• 23701310322790: Endodontic instrument for professional dental use only
• 23701310322783: Endodontic instrument for professional dental use only
• 23701310322776: Endodontic instrument for professional dental use only
• 23701310322769: Endodontic instrument for professional dental use only
• 23701310322752: Endodontic instrument for professional dental use only
• 23701310322745: Endodontic instrument for professional dental use only