DEVICE: Pectoralis Implant (B049ACP13R0)

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Device Identifier (DI) Information

Pectoralis Implant
ACP 1-3 R
ACP 1-3 R
HANSON MEDICAL
B049ACP13R0
HIBCC
1
Non-sterile, silicone, pectoralis implant, right.
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Device Characteristics

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

GMDN

[?]

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

GMDN Preferred Term Name GMDN Definition
Pectoral implant, non-sterile An implantable artificial substitute for the pectoral muscle(s) of the chest. The device is provided non-sterile and is typically made of silicone elastomer that has been moulded into various convex/concave oval shapes. The device is intended for augmentation of the chest by placing the implant submuscular of the natural pectoral(s) and/or for reconstruction of the pectoralis depression caused by Poland's syndrome (congenitally absent pectoral muscle).
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FDA Product Code

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Product Code Product Code Name
MIC Implant, Muscle, Pectoralis
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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 Status

In Commercial Distribution
October 14, 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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