AART Malar Implant Sizer 401-201-5-2A

GUDID B49040120152A0

Szr - Malar Sty 2 Sz 1 L NS

Aart

Malar prosthesis

• Primary Device ID: B49040120152A0
• NIH Device Record Key: e4b6b38e-19f1-4736-be3a-1cb3489804c3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AART Malar Implant Sizer
• Version Model Number: A
• Catalog Number: 401-201-5-2A
• 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	B49040120152A0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K021419

FDA Product Code

• LZK: IMPLANT, MALAR

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 Malar Implant Sizer]

• B49040120262A0: Szr - Malar Sty 2 Sz 2 R NS
• B49040120252A0: Szr - Malar Sty 2 Sz 2 L NS
• B49040120162A0: Szr - Malar Sty 2 Sz 1 R NS
• B49040120152A0: Szr - Malar Sty 2 Sz 1 L NS
• B49040110362A0: Szr - Malar Sty 1 Sz 3 R NS
• B49040110352A0: Szr - Malar Sty 1 Sz 3 L NS
• B49040110262A0: Szr - Malar Sty 1 Sz 2 R NS
• B49040110252A0: Szr - Malar Sty 1 Sz 2 L NS
• B49040110152A0: Szr - Malar Sty 1 Sz 1 L NS