Combined Malar 160-634S

GUDID M724160634S1

Malar Implant

IMPLANTECH ASSOCIATES, INC.

Malar prosthesis Malar prosthesis Malar prosthesis Malar prosthesis Malar prosthesis Malar prosthesis Malar prosthesis Malar prosthesis Malar prosthesis Malar prosthesis Malar prosthesis Malar prosthesis Malar prosthesis Malar prosthesis Malar prosthesis

• Primary Device ID: M724160634S1
• NIH Device Record Key: 999af155-990f-43c8-9dcc-06c8ae576e09
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Combined Malar
• Version Model Number: Size 3
• Catalog Number: 160-634S
• Company DUNS: 784664955
• Company Name: IMPLANTECH ASSOCIATES, INC.
• 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: true
• Expiration Date: true
• 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: 1-800-733-0833
• Email: info@impalntech.com
• Phone: 1-800-733-0833
• Email: info@impalntech.com
• Phone: 1-800-733-0833
• Email: info@impalntech.com
• Phone: 1-800-733-0833
• Email: info@impalntech.com
• Phone: 1-800-733-0833
• Email: info@impalntech.com
• Phone: 1-800-733-0833
• Email: info@impalntech.com
• Phone: 1-800-733-0833
• Email: info@impalntech.com
• Phone: 1-800-733-0833
• Email: info@impalntech.com
• Phone: 1-800-733-0833
• Email: info@impalntech.com
• Phone: 1-800-733-0833
• Email: info@impalntech.com
• Phone: 1-800-733-0833
• Email: info@impalntech.com
• Phone: 1-800-733-0833
• Email: info@impalntech.com
• Phone: 1-800-733-0833
• Email: info@impalntech.com
• Phone: 1-800-733-0833
• Email: info@impalntech.com
• Phone: 1-800-733-0833
• Email: info@impalntech.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M724160634S1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K944165

FDA Product Code

• LZK: Implant, Malar

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-04-21
• Device Publish Date: 2021-04-13

On-Brand Devices [Combined Malar]

• M724160634S1: Malar Implant
• M724160624S1: Malar Implant
• M724160614S1: Malar Implant