ContourFlex™ Calf Implant Sizer CCB7-C1R-SIZ-NS

GUDID M724CCB7C1RSIZNS1

Calf Implant Sizer

IMPLANTECH ASSOCIATES, INC.

Silicone-block tissue reconstructive material Silicone-block tissue reconstructive material Silicone-block tissue reconstructive material Silicone-block tissue reconstructive material Silicone-block tissue reconstructive material Silicone-block tissue reconstructive material Silicone-block tissue reconstructive material Silicone-block tissue reconstructive material Silicone-block tissue reconstructive material Silicone-block tissue reconstructive material Silicone-block tissue reconstructive material Silicone-block tissue reconstructive material Silicone-block tissue reconstructive material Silicone-block tissue reconstructive material Silicone-block tissue reconstructive material Silicone-block tissue reconstructive material

• Primary Device ID: M724CCB7C1RSIZNS1
• NIH Device Record Key: 67b941b5-ea52-4183-8c90-b304987ea3dc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ContourFlex™ Calf Implant Sizer
• Version Model Number: Carlsen Style / Size C1R
• Catalog Number: CCB7-C1R-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	M724CCB7C1RSIZNS1 [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

[M724CCB7C1RSIZNS1]

Moist Heat or Steam Sterilization

[M724CCB7C1RSIZNS1]

Moist Heat or Steam Sterilization

[M724CCB7C1RSIZNS1]

Moist Heat or Steam Sterilization

[M724CCB7C1RSIZNS1]

Moist Heat or Steam Sterilization

[M724CCB7C1RSIZNS1]

Moist Heat or Steam Sterilization

[M724CCB7C1RSIZNS1]

Moist Heat or Steam Sterilization

[M724CCB7C1RSIZNS1]

Moist Heat or Steam Sterilization

[M724CCB7C1RSIZNS1]

Moist Heat or Steam Sterilization

[M724CCB7C1RSIZNS1]

Moist Heat or Steam Sterilization

[M724CCB7C1RSIZNS1]

Moist Heat or Steam Sterilization

[M724CCB7C1RSIZNS1]

Moist Heat or Steam Sterilization

[M724CCB7C1RSIZNS1]

Moist Heat or Steam Sterilization

[M724CCB7C1RSIZNS1]

Moist Heat or Steam Sterilization

[M724CCB7C1RSIZNS1]

Moist Heat or Steam Sterilization

[M724CCB7C1RSIZNS1]

Moist Heat or Steam Sterilization

[M724CCB7C1RSIZNS1]

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

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