DEVICE: Calf Implant (B049CCB21S0)

Device Identifier (DI) Information

Calf Implant
CCB 2-1 S
In Commercial Distribution
CCB 2-1 S
HANSON MEDICAL
B049CCB21S0
HIBCC

1
058759296 *Terms of Use
Non-sterile, silicone, calf implant, sizer.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Silicone-block tissue reconstructive material A non-sterile, solid chunk of silicone elastomer typically modified to suit the patient anatomy and implanted, after sterilization, for tissue reconstruction during a surgical procedure. The device is typically available as a cube with a rectangular cross-section or with curved surfaces. It may be carved or trimmed into different sizes and shapes for various reconstructive or cosmetic plastic surgery procedures that involve soft-tissue or bone augmentation, or the formation of prosthetic implants (e.g., chin or malar). This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
MIB Elastomer, Silicone Block
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K030808 000
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Sterilization

No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

804d4e22-cf50-4355-9370-75cf05c618d6
July 06, 2018
3
October 12, 2015
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
No
No CLOSE

Customer Contact

[?]
1(800)771-2215
erik@hansonmedical.com
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