Contra Angle 32:1

GUDID ENOU5054NOU0

Contra Angle 32:1

Nouvag AG

Line-powered dental drilling/sawing system handpiece

• Primary Device ID: ENOU5054NOU0
• NIH Device Record Key: cdc700c4-fe00-4eae-a360-c80001c044ee
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Contra Angle 32:1
• Version Model Number: 5054NOU
• 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	ENOU5054NOU0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K022505

FDA Product Code

• EGS: Handpiece, Contra- And Right-Angle Attachment, Dental

Sterilization

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

[ENOU5054NOU0]

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 [Contra Angle 32:1]

• ENOU5201NOU0: Contra Angle 32:1 PB
• ENOU5054NOU0: Contra Angle 32:1