SHAPER 20118008

GUDID J015201180089

Endodontic instrument for professionnal dental use only

MICRO MEGA

Endodontic broach, serrated, reusable

• Primary Device ID: J015201180089
• NIH Device Record Key: 52278b5c-bef0-438b-817e-709cdc047664
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SHAPER
• Version Model Number: n25 L25
• Catalog Number: 20118008
• 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	J015201180080 [Unit of Use]
HIBCC	J015201180081 [Primary]
HIBCC	J015201180089 [Package]; Contains: J015201180081; Package: Box [10 Units]; In Commercial Distribution

FDA Product Code

• EKW: Broach, Endodontic

Sterilization

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

[J015201180089]

Moist Heat or Steam Sterilization

[J015201180089]

Moist Heat or Steam Sterilization

[J015201180089]

Moist Heat or Steam Sterilization

[J015201180089]

Moist Heat or Steam Sterilization

[J015201180089]

Moist Heat or Steam Sterilization

[J015201180089]

Moist Heat or Steam Sterilization

[J015201180089]

Moist Heat or Steam Sterilization

[J015201180089]

Moist Heat or Steam Sterilization

[J015201180089]

Moist Heat or Steam Sterilization

[J015201180089]

Moist Heat or Steam Sterilization

[J015201180089]

Moist Heat or Steam Sterilization

[J015201180089]

Moist Heat or Steam Sterilization

[J015201180089]

Moist Heat or Steam Sterilization

[J015201180089]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-09-18
• Device Publish Date: 2020-09-10

On-Brand Devices [SHAPER]

• J015201180049: Endodontic instrument for professionnal dental use only
• J015201180039: Endodontic instrument for professionnal dental use only
• J015201180029: Endodontic instrument for professionnal dental use only
• J015201180011: Endodontic instrument for professionnal dental use only
• J015201180109: Endodontic instrument for professionnal dental use only
• J015201180089: Endodontic instrument for professionnal dental use only
• J015201180079: Endodontic instrument for professionnal dental use only
• J015201180069: Endodontic instrument for professionnal dental use only
• J015201180050: Endodontic instrument for Professional dental use only