DEVICE: Spectrum Designs Medical (B018550111RT1)

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Device Identifier (DI) Information

Spectrum Designs Medical
Pectoral 1, Aiache, Right, Size 1
550-111RT
SPECTRUM DESIGNS INC
B018550111RT1
HIBCC
1
No description.
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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, sterile An implantable artificial substitute for the pectoral muscle(s) of the chest. The device is provided 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

[?]
Product Code Product Code Name
MIC Implant, Muscle, Pectoralis
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Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
October 23, 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

[?]
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
Yes
Yes
Yes
No CLOSE

Customer Contact

[?]
8056847678
service@spectrumdesignsmedical.com
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