Electronic motor 21

GUDID ENOU2116NOU0

Electronic motor 21 Mini E-Type for MD 11 / MD 30

Nouvag AG

Remotely-driven dental drilling system motor

• Primary Device ID: ENOU2116NOU0
• NIH Device Record Key: 0ed8a7ba-b6e3-4900-8083-531ae29b28a6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Electronic motor 21
• Version Model Number: 2116NOU
• Company DUNS: 480610476
• Company Name: Nouvag AG
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• 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

Customer Support Contacts

• Phone: +41718466600
• Email: info@nouvag.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	ENOU2116NOU0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K042434

FDA Product Code

• DZI: Drill, Bone, Powered

Sterilization

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

[ENOU2116NOU0]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-09-13
• Device Publish Date: 2018-08-13

On-Brand Devices [Electronic motor 21]

• ENOU2116NOU0: Electronic motor 21 Mini E-Type for MD 11 / MD 30
• ENOU2101NOU0: Electronic motor 21 for LipoSurg
• ENOU2099NOU0: Electronic motor 21 50'000 RPM
• ENOU2098NOU0: Electronic motor 21 80'000 RPM
• ENOU2097NOU0: Electronic motor 21 for MD 11 / MD 30
• ENOU2090NOU0: Electronic motor 21