ContourFlex™ Gluteal Implant Sizer Anatomical (Teardrop) CCB6-4-SIZ-NS

GUDID M724CCB64SIZNS1

ContourFlex™ Gluteal Implant Sizer Anatomical (Teardrop)

IMPLANTECH ASSOCIATES, INC.

Silicone-block tissue reconstructive material

• Primary Device ID: M724CCB64SIZNS1
• NIH Device Record Key: 7c37b5c1-b1ca-40ac-a888-30fd54710e3c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ContourFlex™ Gluteal Implant Sizer Anatomical (Teardrop)
• Version Model Number: CCB6-4-SIZ-NS
• Catalog Number: CCB6-4-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

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	M724CCB64SIZNS1 [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

[M724CCB64SIZNS1]

Moist Heat or Steam Sterilization

[M724CCB64SIZNS1]

Moist Heat or Steam Sterilization

[M724CCB64SIZNS1]

Moist Heat or Steam Sterilization

[M724CCB64SIZNS1]

Moist Heat or Steam Sterilization

[M724CCB64SIZNS1]

Moist Heat or Steam Sterilization

[M724CCB64SIZNS1]

Moist Heat or Steam Sterilization

[M724CCB64SIZNS1]

Moist Heat or Steam Sterilization

[M724CCB64SIZNS1]

Moist Heat or Steam Sterilization

[M724CCB64SIZNS1]

Moist Heat or Steam Sterilization

[M724CCB64SIZNS1]

Moist Heat or Steam Sterilization

[M724CCB64SIZNS1]

Moist Heat or Steam Sterilization

[M724CCB64SIZNS1]

Moist Heat or Steam Sterilization

[M724CCB64SIZNS1]

Moist Heat or Steam Sterilization

[M724CCB64SIZNS1]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-05-29
• Device Publish Date: 2024-05-21

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• M724ESPF501 - Solid ePTFE Paranasal, Flat Top: 2024-11-11 Solid ePTFE Paranasal, Flat Top
• M724ESPF701 - Solid ePTFE Paranasal, Flat Top: 2024-11-11 Solid ePTFE Paranasal, Flat Top
• M724ESPS501 - Solid ePTFE Paranasal, Sharp Top: 2024-11-11 Solid ePTFE Paranasal, Sharp Top
• M724EST52501 - Solid ePTFE Nasal Dorsum, T Implant: 2024-11-11 Solid ePTFE Nasal Dorsum, T Implant
• M724EST58501 - Solid ePTFE Nasal Dorsum, T Implant: 2024-11-11 Solid ePTFE Nasal Dorsum, T Implant
• M724CCB64SIZNS1 - ContourFlex™ Gluteal Implant Sizer Anatomical (Teardrop): 2024-05-29ContourFlex™ Gluteal Implant Sizer Anatomical (Teardrop)
• M724CCB64SIZNS1 - ContourFlex™ Gluteal Implant Sizer Anatomical (Teardrop): 2024-05-29 ContourFlex™ Gluteal Implant Sizer Anatomical (Teardrop)