Calf Implant CCB 1-5

GUDID B049CCB150

Non-sterile, silicone, calf implant.

HANSON MEDICAL

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

• Primary Device ID: B049CCB150
• NIH Device Record Key: edcff12a-8d4d-4a0f-bf04-20cb28028018
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Calf Implant
• Version Model Number: CCB 1-5
• Catalog Number: CCB 1-5
• Company DUNS: 058759296
• Company Name: HANSON MEDICAL
• 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: false
• 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)771-2215
• Email: erik@hansonmedical.com
• Phone: 1(800)771-2215
• Email: erik@hansonmedical.com
• Phone: 1(800)771-2215
• Email: erik@hansonmedical.com
• Phone: 1(800)771-2215
• Email: erik@hansonmedical.com
• Phone: 1(800)771-2215
• Email: erik@hansonmedical.com
• Phone: 1(800)771-2215
• Email: erik@hansonmedical.com
• Phone: 1(800)771-2215
• Email: erik@hansonmedical.com
• Phone: 1(800)771-2215
• Email: erik@hansonmedical.com
• Phone: 1(800)771-2215
• Email: erik@hansonmedical.com
• Phone: 1(800)771-2215
• Email: erik@hansonmedical.com
• Phone: 1(800)771-2215
• Email: erik@hansonmedical.com
• Phone: 1(800)771-2215
• Email: erik@hansonmedical.com
• Phone: 1(800)771-2215
• Email: erik@hansonmedical.com
• Phone: 1(800)771-2215
• Email: erik@hansonmedical.com
• Phone: 1(800)771-2215
• Email: erik@hansonmedical.com
• Phone: 1(800)771-2215
• Email: erik@hansonmedical.com
• Phone: 1(800)771-2215
• Email: erik@hansonmedical.com
• Phone: 1(800)771-2215
• Email: erik@hansonmedical.com
• Phone: 1(800)771-2215
• Email: erik@hansonmedical.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B049CCB150 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K030808

FDA Product Code

• MIB: Elastomer, Silicone Block

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[B049CCB150]

Moist Heat or Steam Sterilization

[B049CCB150]

Moist Heat or Steam Sterilization

[B049CCB150]

Moist Heat or Steam Sterilization

[B049CCB150]

Moist Heat or Steam Sterilization

[B049CCB150]

Moist Heat or Steam Sterilization

[B049CCB150]

Moist Heat or Steam Sterilization

[B049CCB150]

Moist Heat or Steam Sterilization

[B049CCB150]

Moist Heat or Steam Sterilization

[B049CCB150]

Moist Heat or Steam Sterilization

[B049CCB150]

Moist Heat or Steam Sterilization

[B049CCB150]

Moist Heat or Steam Sterilization

[B049CCB150]

Moist Heat or Steam Sterilization

[B049CCB150]

Moist Heat or Steam Sterilization

[B049CCB150]

Moist Heat or Steam Sterilization

[B049CCB150]

Moist Heat or Steam Sterilization

[B049CCB150]

Moist Heat or Steam Sterilization

[B049CCB150]

Moist Heat or Steam Sterilization

[B049CCB150]

Moist Heat or Steam Sterilization

[B049CCB150]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2015-10-12

On-Brand Devices [Calf Implant]

• B049CCB25S0: Non-sterile, silicone, calf implant, sizer.
• B049CCB250: Non-sterile, silicone, calf implant.
• B049CCB24S0: Non-sterile, silicone, calf implant, sizer.
• B049CCB240: Non-sterile, silicone, calf implant.
• B049CCB23S0: Non-sterile, silicone, calf implant, sizer.
• B049CCB230: Non-sterile, silicone, calf implant.
• B049CCB22S0: Non-sterile, silicone, calf implant, sizer.
• B049CCB220: Non-sterile, silicone, calf implant.
• B049CCB21S0: Non-sterile, silicone, calf implant, sizer.
• B049CCB210: Non-sterile, silicone, calf implant.
• B049CCB15S0: Non-sterile, silicone, calf implant, sizer.
• B049CCB150: Non-sterile, silicone, calf implant.
• B049CCB14S0: Non-sterile, silicone, calf implant, sizer.
• B049CCB140: Non-sterile, silicone, calf implant.
• B049CCB13S0: Non-sterile, silicone, calf implant, sizer.
• B049CCB130: Non-sterile, silicone, calf implant.
• B049CCB12S0: Non-sterile, silicone, calf implant, sizer.
• B049CCB120: Non-sterile, silicone, calf implant.
• B049CCB11S0: Non-sterile, silicone, calf implant, sizer.
• B049CCB110: Non-sterile, silicone, calf implant.