CONSOLE CHIROPRO L PREMIUM 1600855-001

GUDID J00716008550011

Chiropro are electrical medical devices used to run dental instruments

Bien-Air Dental SA

Surgical power tool system control unit, line-powered

• Primary Device ID: J00716008550011
• NIH Device Record Key: 1be4f78f-0267-490d-8bab-6c8704b49f18
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CONSOLE CHIROPRO L PREMIUM
• Version Model Number: 1600855-001
• Catalog Number: 1600855-001
• Company DUNS: 480082080
• Company Name: Bien-Air Dental SA
• 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: false
• 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: +1 949-477-6050
• Email: ba-usa@bienair.com
• Phone: +1 949-477-6050
• Email: ba-usa@bienair.com
• Phone: +1 949-477-6050
• Email: ba-usa@bienair.com
• Phone: +1 949-477-6050
• Email: ba-usa@bienair.com
• Phone: +1 949-477-6050
• Email: ba-usa@bienair.com
• Phone: +1 949-477-6050
• Email: ba-usa@bienair.com
• Phone: +1 949-477-6050
• Email: ba-usa@bienair.com
• Phone: +1 949-477-6050
• Email: ba-usa@bienair.com
• Phone: +1 949-477-6050
• Email: ba-usa@bienair.com
• Phone: +1 949-477-6050
• Email: ba-usa@bienair.com
• Phone: +1 949-477-6050
• Email: ba-usa@bienair.com
• Phone: +1 949-477-6050
• Email: ba-usa@bienair.com
• Phone: +1 949-477-6050
• Email: ba-usa@bienair.com
• Phone: +1 949-477-6050
• Email: ba-usa@bienair.com
• Phone: +1 949-477-6050
• Email: ba-usa@bienair.com
• Phone: +1 949-477-6050
• Email: ba-usa@bienair.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	J00716008550011 [Primary]

FDA Product Code

• EBW: Controller, foot, handpiece and cord

Sterilization

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

[J00716008550011]

Moist Heat or Steam Sterilization

[J00716008550011]

Moist Heat or Steam Sterilization

[J00716008550011]

Moist Heat or Steam Sterilization

[J00716008550011]

Moist Heat or Steam Sterilization

[J00716008550011]

Moist Heat or Steam Sterilization

[J00716008550011]

Moist Heat or Steam Sterilization

[J00716008550011]

Moist Heat or Steam Sterilization

[J00716008550011]

Moist Heat or Steam Sterilization

[J00716008550011]

Moist Heat or Steam Sterilization

[J00716008550011]

Moist Heat or Steam Sterilization

[J00716008550011]

Moist Heat or Steam Sterilization

[J00716008550011]

Moist Heat or Steam Sterilization

[J00716008550011]

Moist Heat or Steam Sterilization

[J00716008550011]

Moist Heat or Steam Sterilization

[J00716008550011]

Moist Heat or Steam Sterilization

[J00716008550011]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-06-25
• Device Publish Date: 2021-06-17

On-Brand Devices [CONSOLE CHIROPRO L PREMIUM]

• J00716008550011: Chiropro are electrical medical devices used to run dental instruments
• J00716008290011: Chiropro are electrical medical devices used to run dental instruments