Conform Terino Malar Shell® CTMS-L4

GUDID M724CTMSL41

Malar Implant

IMPLANTECH ASSOCIATES, INC.

Malar prosthesis

• Primary Device ID: M724CTMSL41
• NIH Device Record Key: 72a05435-1bf4-4e44-b57e-9783a2086896
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Conform Terino Malar Shell®
• Version Model Number: Size: Large
• Catalog Number: CTMS-L4
• 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@implantech.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M724CTMSL41 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K901662

FDA Product Code

• LZK: Implant, Malar

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-11-15
• Device Publish Date: 2015-09-24

On-Brand Devices [Conform Terino Malar Shell®]

• M724CTMSXL41: Malar Implant
• M724CTMSM41: Malar Implant
• M724CTMSS41: Malar Implant
• M724CTMSL41: Malar Implant