HighSurg 11

GUDID ENOU33910

Surgical motor system

Nouvag AG

Line-powered surgical power tool system motor

• Primary Device ID: ENOU33910
• NIH Device Record Key: ddfbd4a5-fa09-45c7-9407-4793c4930f41
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HighSurg 11
• Version Model Number: 3391
• 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	ENOU33910 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K042434

FDA Product Code

• ERL: Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece

Sterilization

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

[ENOU33910]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-09-21
• Device Publish Date: 2018-08-21

On-Brand Devices [HighSurg 11]

• ENOU3391FOC0: Surgical motor system
• ENOU33910: Surgical motor system
• ENOU33610: Surgical motor system