ContourFlex™ Gluteal Implant Sizer Round CCB5-SIZ-5-NS

GUDID M724CCB5SIZ5NS1

ContourFlex™ Gluteal Implant Sizer Round

IMPLANTECH ASSOCIATES, INC.

Silicone-block tissue reconstructive material

• Primary Device ID: M724CCB5SIZ5NS1
• NIH Device Record Key: c514fb01-e8e7-44f4-8c14-a9ae27faf5c0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ContourFlex™ Gluteal Implant Sizer Round
• Version Model Number: CCB5-SIZ-5
• Catalog Number: CCB5-SIZ-5-NS
• 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: false
• 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
• 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	M724CCB5SIZ5NS1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K052504

FDA Product Code

• MIB: Elastomer, Silicone Block

Sterilization

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

[M724CCB5SIZ5NS1]

Moist Heat or Steam Sterilization

[M724CCB5SIZ5NS1]

Moist Heat or Steam Sterilization

[M724CCB5SIZ5NS1]

Moist Heat or Steam Sterilization

[M724CCB5SIZ5NS1]

Moist Heat or Steam Sterilization

[M724CCB5SIZ5NS1]

Moist Heat or Steam Sterilization

[M724CCB5SIZ5NS1]

Moist Heat or Steam Sterilization

[M724CCB5SIZ5NS1]

Moist Heat or Steam Sterilization

[M724CCB5SIZ5NS1]

Moist Heat or Steam Sterilization

[M724CCB5SIZ5NS1]

Moist Heat or Steam Sterilization

[M724CCB5SIZ5NS1]

Moist Heat or Steam Sterilization

[M724CCB5SIZ5NS1]

Moist Heat or Steam Sterilization

[M724CCB5SIZ5NS1]

Moist Heat or Steam Sterilization

[M724CCB5SIZ5NS1]

Moist Heat or Steam Sterilization

[M724CCB5SIZ5NS1]

Moist Heat or Steam Sterilization

[M724CCB5SIZ5NS1]

Moist Heat or Steam Sterilization

[M724CCB5SIZ5NS1]

Moist Heat or Steam Sterilization

[M724CCB5SIZ5NS1]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-05-28
• Device Publish Date: 2024-05-20

On-Brand Devices [ContourFlex™ Gluteal Implant Sizer Round]

• M724CCB5SIZ6NS1: ContourFlex™ Gluteal Implant Sizer Round
• M724CCB5SIZ5NS1: ContourFlex™ Gluteal Implant Sizer Round