ContourFlex™ Calf Implant Sizer CCB7-C3R-SIZ-NS

GUDID M724CCB7C3RSIZNS1

Calf Implant Sizer

IMPLANTECH ASSOCIATES, INC.

Silicone-block tissue reconstructive material

• Primary Device ID: M724CCB7C3RSIZNS1
• NIH Device Record Key: e3915e86-4cd2-4d7c-9662-aac894ea0715
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ContourFlex™ Calf Implant Sizer
• Version Model Number: Carlsen Style / Size C3R
• Catalog Number: CCB7-C3R-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
• 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	M724CCB7C3RSIZNS1 [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

[M724CCB7C3RSIZNS1]

Moist Heat or Steam Sterilization

[M724CCB7C3RSIZNS1]

Moist Heat or Steam Sterilization

[M724CCB7C3RSIZNS1]

Moist Heat or Steam Sterilization

[M724CCB7C3RSIZNS1]

Moist Heat or Steam Sterilization

[M724CCB7C3RSIZNS1]

Moist Heat or Steam Sterilization

[M724CCB7C3RSIZNS1]

Moist Heat or Steam Sterilization

[M724CCB7C3RSIZNS1]

Moist Heat or Steam Sterilization

[M724CCB7C3RSIZNS1]

Moist Heat or Steam Sterilization

[M724CCB7C3RSIZNS1]

Moist Heat or Steam Sterilization

[M724CCB7C3RSIZNS1]

Moist Heat or Steam Sterilization

[M724CCB7C3RSIZNS1]

Moist Heat or Steam Sterilization

[M724CCB7C3RSIZNS1]

Moist Heat or Steam Sterilization

[M724CCB7C3RSIZNS1]

Moist Heat or Steam Sterilization

[M724CCB7C3RSIZNS1]

Moist Heat or Steam Sterilization

[M724CCB7C3RSIZNS1]

Moist Heat or Steam Sterilization

[M724CCB7C3RSIZNS1]

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

On-Brand Devices [ContourFlex™ Calf Implant Sizer]

• M724CCB7SIZ2NS1: Calf Implant Sizer
• M724CCB7C3RSIZNS1: Calf Implant Sizer
• M724CCB7C3LSIZNS: Calf Implant Sizer
• M724CCB7C2RSIZNS1: Calf Implant Sizer
• M724CCB7C2LSIZNS1: Calf Implant Sizer
• M724CCB7C1RSIZNS1: Calf Implant Sizer
• M724CCB7C1LSIZNS1: Calf Implant Sizer
• M724CCB791SIZNS1: Calf Implant Sizer
• M724CCB781SIZNS1: Calf Implant Sizer
• M724CCB771SIZNS1: Calf Implant Sizer
• M724CCB761SIZNS1: Calf Implant Sizer
• M724CCB751SIZNS1: Calf Implant Sizer
• M724CCB741SIZNS1: Calf Implant Sizer
• M724CCB731SIZNS1: Calf Implant Sizer
• M724CCB721SIZNS1: Calf Implant Sizer
• M724CCB711SIZNS1: Calf Implant Sizer