DEVICE: MENTOR CENTERSCOPE Magnetic Detection Device (00081317004042)

Device Identifier (DI) Information

MENTOR CENTERSCOPE Magnetic Detection Device
350-4402
In Commercial Distribution
350-4402
MENTOR TEXAS L.P.
00081317004042
GS1

1
167450993 *Terms of Use
No description.
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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
Tissue expander injection port locator A small, hand-held, manually-operated, sterile device designed to assist with the location of the subcutaneous injection port of an implanted tissue expander prior to the insertion of a filling needle into the port in order to fill the tissue expander with, e.g., saline. It is moved over the surface of the skin at the point where the concealed injection site is situated and an indicator, e.g., a small magnet, reacts to the metal material of the port, indicating where it is located. Repetition of this locating process on several axes provides the exact location of the injection site. 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 [?]
K011500 000
K130813 000
K150777 000
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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

[?]
Size Type Text
No Device Sizes
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Device Record Status

dd244a7f-f7b8-4f80-b58c-627419f9294d
July 06, 2018
3
September 21, 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
Yes
No
No CLOSE

Customer Contact

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