Gluteal Implant, Round, Textured, SDM CCB6-T-72

GUDID M724CCB6T721

Gluteal Implant

IMPLANTECH ASSOCIATES, INC.

Silicone-block tissue reconstructive material

• Primary Device ID: M724CCB6T721
• NIH Device Record Key: e5de9fed-e3b8-4c2a-8b14-e309bf86bd2f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Gluteal Implant, Round, Textured, SDM
• Version Model Number: Size: 16.0cm x 11.0cm x 3.0cm
• Catalog Number: CCB6-T-72
• 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
• 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	M724CCB6T721 [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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-11-14
• Device Publish Date: 2017-08-07

On-Brand Devices [Gluteal Implant, Round, Textured, SDM]

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• M724CCB6T831: Gluteal Implant
• M724CCB6T741: Gluteal Implant
• M724CCB6T731: Gluteal Implant
• M724CCB6T711: Gluteal Implant
• M724CCB5T531: Gluteal Implant
• M724CCB5T521: Gluteal Implant
• M724CCB5T511: Gluteal Implant
• M724CCB6T821: Gluteal Implant
• M724CCB6T811: Gluteal Implant
• M724CCB6T721: Gluteal Implant
• M724CCB5T561: Gluteal Implant
• M724CCB5T551: Gluteal Implant
• M724CCB5T541: Gluteal Implant