AART Chin Implant Sizer 400-104-2A

GUDID B4904001042A0

Szr - Chin Sty 1 Sz 4 NS

Aart

Chin prosthesis

• Primary Device ID: B4904001042A0
• NIH Device Record Key: 18b528e8-880e-46ad-99ff-c7c7f99db6da
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AART Chin Implant Sizer
• Version Model Number: A
• Catalog Number: 400-104-2A
• 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	B4904001042A0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K021417

FDA Product Code

• FWP: PROSTHESIS, CHIN, INTERNAL

Sterilization

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

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 Sizer]

• B4904003032A0: Szr - Chin Sty 3 Sz 3 NS
• B4904003022A0: Szr - Chin Sty 3 Sz 2 NS
• B4904003012A0: Szr - Chin Sty 3 Sz 1 NS
• B4904002022A0: Szr - Chin Sty 2 Sz 2 NS
• B4904002012A0: Szr - Chin Sty 2 Sz 1 NS
• B4904001042A0: Szr - Chin Sty 1 Sz 4 NS
• B4904001032A0: Szr - Chin Sty 1 Sz 3 NS
• B4904001022A0: Szr - Chin Sty 1 Sz 2 NS
• B4904001012A0: Szr - Chin Sty 1 Sz 1 NS