AART Chin Implant 400-201B

GUDID B490400201B0

Chin Sty 2 Sz 1 Sterile

Aart

Chin prosthesis Chin prosthesis

• Primary Device ID: B490400201B0
• NIH Device Record Key: a0de3050-a644-4e2a-a77b-60a04378956b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AART Chin Implant
• Version Model Number: B
• Catalog Number: 400-201B
• Company DUNS: 091356894
• Company Name: Aart
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(775)853-6800
• Email: customer.service@aartinc.net
• Phone: +1(775)853-6800
• Email: customer.service@aartinc.net

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B490400201B0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K021417

FDA Product Code

• FWP: PROSTHESIS, CHIN, INTERNAL

Sterilization

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

[B490400201B0]

Dry Heat Sterilization

[B490400201B0]

Dry Heat Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-12-20

On-Brand Devices [AART Chin Implant]

• B490400303B0: Chin Sty 3 Sz 3 Sterile
• B490400302B0: Chin Sty 3 Sz 2 Sterile
• B490400301B0: Chin Sty 3 Sz 1 Sterile
• B490400202B0: Chin Sty 2 Sz 2 Sterile
• B490400201B0: Chin Sty 2 Sz 1 Sterile
• B490400104B0: Chin Sty 1 Sz 4 Sterile
• B490400103B0: Chin Sty 1 Sz 3 Sterile
• B490400102B0: Chin Sty 1 Sz 2 Sterile
• B490400101B0: Chin Sty 1 Sz 1 Sterile