DEVICE: Biopsy Handy (04250195601926)

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Device Identifier (DI) Information

Biopsy Handy
900138

SOMATEX Medical Technologies GmbH
04250195601926
GS1
1
No description.
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Device Characteristics

MR Unsafe
No
Yes
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
End-cut biopsy gun, single-use A sterile hand-operated surgical instrument designed for the automatic extraction of a core tissue sample from an anatomic structure of the body (i.e., a biopsy), while causing minimal surrounding tissue damage, for pathological examination/testing. It has a spring-loaded mechanism intended for transcutaneous insertion of its distal needle-like portion. It has an open cylindrical needle that allows a full-width tissue sample to be obtained over the entire length of the biopsy when activated. It is typically used to obtain samples of soft tissue from the kidneys, prostate, pancreas, liver, and breast, often performed under image guidance. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
KNW Instrument, Biopsy
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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 Status

In Commercial Distribution
October 11, 2016

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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
04250195606198 10 04250195601926 In Commercial Distribution
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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
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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