ONE SHAPE APICAL 20949211

GUDID J015209492119

Endodontic instrument for professionnal use only

MICRO MEGA

Rotary/reciprocating endodontic file/rasp, single-use

• Primary Device ID: J015209492119
• NIH Device Record Key: 08a3489a-5177-409f-a387-683f9bb96648
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ONE SHAPE APICAL
• Version Model Number: n037 6% L21
• Catalog Number: 20949211
• Company DUNS: 276075371
• Company Name: MICRO MEGA
• Device Count: 5
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	J015209492110 [Unit of Use]
HIBCC	J015209492111 [Primary]
HIBCC	J015209492119 [Package]; Contains: J015209492111; Package: Box [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: 2020-09-07
• Device Publish Date: 2020-08-28

On-Brand Devices [ONE SHAPE APICAL]

• J015209492011: Endodontic instrument for professionnal dental use only
• J015209492139: Endodontic instrument for professionnal dental use only
• J015209492129: Endodontic instrument for professionnal dental use only
• J015209492119: Endodontic instrument for professionnal use only
• J015209492029: Endodontic instrument for professionnal dental use only