MD 11

GUDID ENOU3335OXY0

Dental implant motor system

Nouvag AG

Remotely-driven dental drilling system motor

• Primary Device ID: ENOU3335OXY0
• NIH Device Record Key: 4bdfb526-bb3c-4708-a776-4f20ba65c65f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MD 11
• Version Model Number: 3335OXY
• 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	ENOU3335OXY0 [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

[ENOU3335OXY0]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-10-01
• Device Publish Date: 2018-08-31

On-Brand Devices [MD 11]

• ENOU3335SAL0: Dental implant motor system
• ENOU3335OXY0: Dental implant motor system
• ENOU3335IDI0: Dental implant motor system
• ENOU3335ABD0: Dental implant motor system
• ENOU33350: Dental implant motor system
• ENOU2028OXY0: Dental implant motor System, SET
• ENOU2028IDI0: Dental implant motor System, SET
• ENOU2028ABD0: Dental implant motor System, SET
• ENOU20280: Dental implant motor System, SET
• ENOU2027SAL0: Dental implant motor System, SET
• ENOU2027OXY0: Dental implant motor System, SET
• ENOU2027M0: Dental implant motor System, SET
• ENOU2027IDI0: Dental implant motor System, SET
• ENOU2027ABD0: Dental implant motor System, SET
• ENOU20270: Dental implant motor System, SET
• ENOU2026IDI0: Dental implant motor System, SET
• ENOU20260: Dental implant motor System, SET