ContourFlex™ Gluteal Implant, Smooth (Round) CCB5-S-56

GUDID M724CCB5S561

Gluteal Implant

IMPLANTECH ASSOCIATES, INC.

Silicone-block tissue reconstructive material

• Primary Device ID: M724CCB5S561
• NIH Device Record Key: 6324b151-7548-495b-8340-17ad64577cad
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ContourFlex™ Gluteal Implant, Smooth (Round)
• Version Model Number: Size: 16.0cm x 16.0cm x 4.8cm
• Catalog Number: CCB5-S-56
• 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
• Phone: 1-800-733-0833
• Email: info@implantech.com
• Phone: 1-800-733-0833
• Email: info@implantech.com
• Phone: 1-800-733-0833
• Email: info@implantech.com
• Phone: 1-800-733-0833
• Email: info@implantech.com
• Phone: 1-800-733-0833
• Email: info@implantech.com
• Phone: 1-800-733-0833
• Email: info@implantech.com
• Phone: 1-800-733-0833
• Email: info@implantech.com
• Phone: 1-800-733-0833
• Email: info@implantech.com
• Phone: 1-800-733-0833
• Email: info@implantech.com
• Phone: 1-800-733-0833
• Email: info@implantech.com
• Phone: 1-800-733-0833
• Email: info@implantech.com
• Phone: 1-800-733-0833
• Email: info@implantech.com
• Phone: 1-800-733-0833
• Email: info@implantech.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M724CCB5S561 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K982688

FDA Product Code

• MIB: Elastomer, Silicone Block

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: 2021-04-07
• Device Publish Date: 2021-03-30

On-Brand Devices [ContourFlex™ Gluteal Implant, Smooth (Round)]

• M724CCB5S561: Gluteal Implant
• M724CCB5S551: Gluteal Implant
• M724CCB5S541: Gluteal Implant
• M724CCB5S531: Gluteal Implant
• M724CCB5S521: Gluteal Implant
• M724CCB5S511: Gluteal Implant