2Shape Mini 20153211

GUDID J015201532119

Endodontic instruments for professionnal dental use only

MICRO MEGA

Rotary/reciprocating endodontic file/rasp, reusable

• Primary Device ID: J015201532119
• NIH Device Record Key: 8451237c-e1df-434b-ba75-72bd17893966
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 2Shape Mini
• Version Model Number: TS1 n25 4% L25 Classics
• Catalog Number: 20153211
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	J015201532110 [Unit of Use]
HIBCC	J015201532111 [Primary]
HIBCC	J015201532119 [Package]; Contains: J015201532111; Package: [10 Units]; In Commercial Distribution

FDA Product Code

• EKS: File, Pulp Canal, Endodontic

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[J015201532119]

Moist Heat or Steam Sterilization

[J015201532119]

Moist Heat or Steam Sterilization

[J015201532119]

Moist Heat or Steam Sterilization

[J015201532119]

Moist Heat or Steam Sterilization

[J015201532119]

Moist Heat or Steam Sterilization

[J015201532119]

Moist Heat or Steam Sterilization

[J015201532119]

Moist Heat or Steam Sterilization

[J015201532119]

Moist Heat or Steam Sterilization

[J015201532119]

Moist Heat or Steam Sterilization

[J015201532119]

Moist Heat or Steam Sterilization

[J015201532119]

Moist Heat or Steam Sterilization

[J015201532119]

Moist Heat or Steam Sterilization

[J015201532119]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-09-29
• Device Publish Date: 2022-09-21

On-Brand Devices [2Shape Mini]

• J015209532339: Endodontic instrument for professionnal dental use only
• J015209532329: Endodontic instrument for professionnal dental use only
• J015209532319: Endodontic instrument for professionnal dental use only
• J015209532249: Endodontic instrument for professionnal dental use only
• J015209532239: Endodontic instrument for professionnal dental use only
• J015209532229: Endodontic instrument for professionnal dental use only
• J015209532219: Endodontic instrument for professionnal dental use only
• J015209532149: Endodontic instrument for professionnal dental use only
• J015209532139: Endodontic instrument for professionnal dental use only
• J015209532129: Endodontic instrument for professionnal dental use only
• J015209532119: Endodontic instrument for professionnal dental use only
• J015209532040: Endodontic instrument for professionnal dental use only
• J015209532039: Endodontic instrument for professionnal dental use only
• J015209532029: Endodontic instrument for professionnal dental use only
• J015209532019: Endodontic instrument for professionnal dental use only
• J015201532339: Endodontic instruments for professionnal dental use only
• J015201532329: Endodontic instruments for professionnal dental use only
• J015201532319: Endodontic instruments for professionnal dental use only
• J015201532249: Endodontic instruments for professionnal dental use only
• J015201532239: Endodontic instruments for professionnal dental use only
• J015201532229: Endodontic instruments for professionnal dental use only
• J015201532219: Endodontic instruments for professionnal dental use only
• J015201532149: Endodontic instruments for professionnal dental use only
• J015201532139: Endodontic instruments for professionnal dental use only
• J015201532129: Endodontic instruments for professionnal dental use only
• J015201532119: Endodontic instruments for professionnal dental use only
• J015201532049: Endodontic instruments for professionnal dental use only
• J015201532039: Endodontic instruments for professionnal dental use only
• J015201532029: Endodontic instruments for professionnal dental use only
• J015201532019: Endodontic instruments for professionnal dental use only