SHAPER 20118003

GUDID J015201180039

Endodontic instrument for professionnal dental use only

MICRO MEGA

Endodontic broach, serrated, reusable Endodontic broach, serrated, reusable Endodontic broach, serrated, reusable Endodontic broach, serrated, reusable Endodontic broach, serrated, reusable Endodontic broach, serrated, reusable Endodontic broach, serrated, reusable Endodontic broach, serrated, reusable Endodontic broach, serrated, reusable Endodontic broach, serrated, reusable Endodontic broach, serrated, reusable Endodontic broach, serrated, reusable Endodontic broach, serrated, reusable Endodontic broach, serrated, reusable

• Primary Device ID: J015201180039
• NIH Device Record Key: 1f2dfe98-2eba-43f5-ac55-f0ccef4df5a9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SHAPER
• Version Model Number: n15 L21 ISO M10
• Catalog Number: 20118003
• 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	J015201180030 [Unit of Use]
HIBCC	J015201180031 [Primary]
HIBCC	J015201180039 [Package]; Contains: J015201180031; Package: Box [10 Units]; In Commercial Distribution

FDA Product Code

• EKW: Broach, Endodontic

Sterilization

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

[J015201180039]

Moist Heat or Steam Sterilization

[J015201180039]

Moist Heat or Steam Sterilization

[J015201180039]

Moist Heat or Steam Sterilization

[J015201180039]

Moist Heat or Steam Sterilization

[J015201180039]

Moist Heat or Steam Sterilization

[J015201180039]

Moist Heat or Steam Sterilization

[J015201180039]

Moist Heat or Steam Sterilization

[J015201180039]

Moist Heat or Steam Sterilization

[J015201180039]

Moist Heat or Steam Sterilization

[J015201180039]

Moist Heat or Steam Sterilization

[J015201180039]

Moist Heat or Steam Sterilization

[J015201180039]

Moist Heat or Steam Sterilization

[J015201180039]

Moist Heat or Steam Sterilization

[J015201180039]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-08-31
• Device Publish Date: 2020-08-21

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