Contoured Carving Block Style 8 CCB8-2

GUDID M724CCB821

Contoured Carving Block Implant

IMPLANTECH ASSOCIATES, INC.

Silicone-block tissue reconstructive material

• Primary Device ID: M724CCB821
• NIH Device Record Key: 11e7e05c-3de9-41cc-ade8-c881375a266b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Contoured Carving Block Style 8
• Version Model Number: Size 2
• Catalog Number: CCB8-2
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M724CCB821 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K952706

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: 4
• Public Version Date: 2019-11-15
• Device Publish Date: 2015-09-24

On-Brand Devices [Contoured Carving Block Style 8]

• M724CCB841: Contoured Carving Block Implant
• M724CCB831: Contoured Carving Block Implant
• M724CCB811: Contoured Carving Block Implant
• M724CCB851: Contoured Carving Block Implant
• M724CCB821: Contoured Carving Block Implant