ContourFlex™ Gluteal Implant Sizer CCB5-SIZ-1-NS

GUDID M724CCB5SIZ1NS1

ContourFlex™ Gluteal Implant Sizer

IMPLANTECH ASSOCIATES, INC.

Silicone-block tissue reconstructive material

• Primary Device ID: M724CCB5SIZ1NS1
• NIH Device Record Key: fc133a07-4b66-4953-9e8f-12d96e3dac81
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ContourFlex™ Gluteal Implant Sizer
• Version Model Number: CCB5-SIZ-1
• Catalog Number: CCB5-SIZ-1-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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M724CCB5SIZ1NS1 [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

[M724CCB5SIZ1NS1]

Moist Heat or Steam Sterilization

[M724CCB5SIZ1NS1]

Moist Heat or Steam Sterilization

[M724CCB5SIZ1NS1]

Moist Heat or Steam Sterilization

[M724CCB5SIZ1NS1]

Moist Heat or Steam Sterilization

[M724CCB5SIZ1NS1]

Moist Heat or Steam Sterilization

[M724CCB5SIZ1NS1]

Moist Heat or Steam Sterilization

[M724CCB5SIZ1NS1]

Moist Heat or Steam Sterilization

[M724CCB5SIZ1NS1]

Moist Heat or Steam Sterilization

[M724CCB5SIZ1NS1]

Moist Heat or Steam Sterilization

[M724CCB5SIZ1NS1]

Moist Heat or Steam Sterilization

[M724CCB5SIZ1NS1]

Moist Heat or Steam Sterilization

[M724CCB5SIZ1NS1]

Moist Heat or Steam Sterilization

[M724CCB5SIZ1NS1]

Moist Heat or Steam Sterilization

[M724CCB5SIZ1NS1]

Moist Heat or Steam Sterilization

[M724CCB5SIZ1NS1]

Moist Heat or Steam Sterilization

[M724CCB5SIZ1NS1]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2024-05-21
• Device Publish Date: 2017-10-17

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• M724CCB554SIZNS1: Gluteal Implant Sizer
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• M724CCB552SIZNS1: Gluteal Implant Sizer
• M724CCB551SIZNS1: Gluteal Implant Sizer
• M724CCB6SIZ3NS1: ContourFlex™ Gluteal Implant Sizer
• M724CCB6SIZ1NS1: ContourFlex™ Gluteal Implant Sizer
• M724CCB5SIZ4NS1: ContourFlex™ Gluteal Implant Sizer
• M724CCB5SIZ3NS1: ContourFlex™ Gluteal Implant Sizer
• M724CCB5SIZ2NS1: ContourFlex™ Gluteal Implant Sizer
• M724CCB5SIZ1NS1: ContourFlex™ Gluteal Implant Sizer
• M724CCB5SIZ0NS1: ContourFlex™ Gluteal Implant Sizer