Calf Implant, Smooth SDM CCB7-S-81

GUDID M724CCB7S811

Calf Implant

IMPLANTECH ASSOCIATES, INC.

Silicone-block tissue reconstructive material

• Primary Device ID: M724CCB7S811
• NIH Device Record Key: 486cdccb-0ded-4a4a-a389-2b6c1a8fc084
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Calf Implant, Smooth SDM
• Version Model Number: Size: 16.5cm x 7.2cm x 1.6cm
• Catalog Number: CCB7-S-81
• Company DUNS: 784664955
• Company Name: IMPLANTECH ASSOCIATES, INC.
• Device Count: 1
• DM Exempt: true
• 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	M724CCB7S811 [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: 2019-11-13
• Device Publish Date: 2017-08-07

On-Brand Devices [Calf Implant, Smooth SDM]

• M724CCB7S811: Calf Implant
• M724CCB7S711: Calf Implant
• M724CCB7S511: Calf Implant
• M724CCB7S311: Calf Implant
• M724CCB7S211: Calf Implant
• M724CCB7S111: Calf Implant
• M724CCB7S911: Calf Implant
• M724CCB7S411: Calf Implant