DEVICE: MENTOR CPX 3 Breast Tissue Expander with Suturing Tabs (00081317003649)

Device Identifier (DI) Information

MENTOR CPX 3 Breast Tissue Expander with Suturing Tabs
3547114
Not in Commercial Distribution
354-7114
MENTOR TEXAS L.P.
00081317003649
GS1
February 10, 2021
1
167450993 *Terms of Use
SILTEX Low Height Tissue Expander Style 7100, 550cc
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Device Characteristics

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

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
45187 Skin-port tissue expander
An expandable device intended for implantation to temporarily enlarge tissue, typically the dimensions of a skin flap where there is insufficient tissue coverage to accommodate the volume of an 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 expanded percutaneously with air or fluid through a subcutaneous port accessed by a healthcare professional. This is a single-use device.
Active true
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FDA Product Code

[?]
Product Code Product Code Name
LCJ EXPANDER, SKIN, INFLATABLE
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K011500 000
No CLOSE

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 Record Status

ab7fcc68-c64a-4ccc-a99f-7c1c5a540923
February 11, 2021
5
September 07, 2015
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
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

[?]
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
No
No CLOSE

Customer Contact

[?]
+1(800)235-5731
xx@xx.xx
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