ContourFlex™ Gluteal Implant Sizer CCB5-54-SIZ-NS

GUDID M724CCB554SIZNS1

Gluteal Implant Sizer

IMPLANTECH ASSOCIATES, INC.

Silicone-block tissue reconstructive material

• Primary Device ID: M724CCB554SIZNS1
• NIH Device Record Key: 3dd8ef42-ea3e-453d-a7b6-b59d19af1edc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ContourFlex™ Gluteal Implant Sizer
• Version Model Number: Round / Size 54
• Catalog Number: CCB5-54-SIZ-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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M724CCB554SIZNS1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K982688

FDA Product Code

• MIB: Elastomer, Silicone Block

Sterilization

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

[M724CCB554SIZNS1]

Moist Heat or Steam Sterilization

[M724CCB554SIZNS1]

Moist Heat or Steam Sterilization

[M724CCB554SIZNS1]

Moist Heat or Steam Sterilization

[M724CCB554SIZNS1]

Moist Heat or Steam Sterilization

[M724CCB554SIZNS1]

Moist Heat or Steam Sterilization

[M724CCB554SIZNS1]

Moist Heat or Steam Sterilization

[M724CCB554SIZNS1]

Moist Heat or Steam Sterilization

[M724CCB554SIZNS1]

Moist Heat or Steam Sterilization

[M724CCB554SIZNS1]

Moist Heat or Steam Sterilization

[M724CCB554SIZNS1]

Moist Heat or Steam Sterilization

[M724CCB554SIZNS1]

Moist Heat or Steam Sterilization

[M724CCB554SIZNS1]

Moist Heat or Steam Sterilization

[M724CCB554SIZNS1]

Moist Heat or Steam Sterilization

[M724CCB554SIZNS1]

Moist Heat or Steam Sterilization

[M724CCB554SIZNS1]

Moist Heat or Steam Sterilization

[M724CCB554SIZNS1]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-02-15
• Device Publish Date: 2022-02-07

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• M724CCB555SIZNS1: Gluteal Implant Sizer
• M724CCB554SIZNS1: Gluteal Implant Sizer
• M724CCB553SIZNS1: Gluteal Implant Sizer
• M724CCB552SIZNS1: Gluteal Implant Sizer
• M724CCB551SIZNS1: Gluteal Implant Sizer
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• M724CCB5SIZ3NS1: ContourFlex™ Gluteal Implant Sizer
• M724CCB5SIZ2NS1: ContourFlex™ Gluteal Implant Sizer
• M724CCB5SIZ1NS1: ContourFlex™ Gluteal Implant Sizer
• M724CCB5SIZ0NS1: ContourFlex™ Gluteal Implant Sizer