DEVICE: MENTOR Tissue Expander (00081317002482)

Device Identifier (DI) Information

MENTOR Tissue Expander
3504312M
In Commercial Distribution
3504312M
MENTOR TEXAS L.P.
00081317002482
GS1

1
167450993 *Terms of Use
Smooth Crescent, 50cc
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
Yes
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
Tissue expander An sterile inflatable device intended to be temporarily implanted to enlarge tissue, typically the dimensions of a skin flap where there is insufficient tissue coverage to accommodate the volume of a long-term implantable device (e.g., a breast implant), or for the revision of a scar or cutaneous defect. The device typically consists of an expansion envelope (e.g., silicone elastomer) with fill tube, and an inflation valve, and is managed by a healthcare professional. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
LCJ EXPANDER, SKIN, INFLATABLE
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K842883 000
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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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

410ab9a9-4bca-49a5-afbd-d4d1cac4e99d
July 06, 2018
3
September 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
Yes
Yes
No
No CLOSE

Customer Contact

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+1(800)235-5731
xx@xx.xx
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