EdgeTaper Blaze Utopia ETBUS221S

GUDID 23701310370104

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

• Primary Device ID: 23701310370104
• NIH Device Record Key: 873df4d4-0a36-4cc9-842e-ac7a8b7d1579
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EdgeTaper Blaze Utopia
• Version Model Number: S2 L21 Sterile
• Catalog Number: ETBUS221S
• 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
• 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
GS1	03701310370100 [Primary]
GS1	23701310370104 [Package]; Contains: 03701310370100; 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: 2023-10-09
• Device Publish Date: 2023-09-29

On-Brand Devices [EdgeTaper Blaze Utopia]

• 23701310370067: Endodontic instrument for professional dental use only
• 23701310370241: Endodontic instrument for professional dental use only
• 23701310370234: Endodontic instrument for professional dental use only
• 23701310370227: Endodontic instrument for professional dental use only
• 23701310370210: Endodontic instrument for professional dental use only
• 23701310370203: Endodontic instrument for professional dental use only
• 23701310370197: Endodontic instrument for professional dental use only
• 23701310370180: Endodontic instrument for professional dental use only
• 23701310370173: Endodontic instrument for professional dental use only
• 23701310370166: Endodontic instrument for professional dental use only
• 23701310370159: Endodontic instrument for professional dental use only
• 23701310370142: Endodontic instrument for professional dental use only
• 23701310370135: Endodontic instrument for professional dental use only
• 23701310370128: Endodontic instrument for professional dental use only
• 23701310370111: Endodontic instrument for professional dental use only
• 23701310370104: Endodontic instrument for professional dental use only
• 23701310370098: Endodontic instrument for professional dental use only
• 03701310370087: Endodontic instrument for professional dental use only
• 23701310370074: Endodontic instrument for professional dental use only