DEVICE: Gynosampler (05425017500377)

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Device Identifier (DI) Information

Gynosampler
#9164

Gynetics Medical Products NV
05425017500377
GS1
1
The Gynosampler is an endometrial suction curette for a histologic lining biopsy.
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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
Endometrial biopsy kit A collection of sterile devices designed for the collection of a tissue sample taken from the lining of the uterus (endometrium). It typically includes an aspirating curette, a specimen container and other materials. It is used in the study of endometrial cytology (cells). This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
HFF Aspirator, Endometrial
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Sterilization

Yes
Yes
Sterilization Method [?]
Ethylene Oxide
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Storage and Handling

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Storage and Handling
Storage Environment Temperature: between 0 and 30 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
Outer Diameter: 2.93 Millimeter
Length: 262 Millimeter
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Device Status

In Commercial Distribution
October 04, 2016

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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
15425017500374 25 05425017500377 In Commercial Distribution
75425017500376 250 05425017500377 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)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
Yes
No CLOSE

Customer Contact

[?]
+3211645872
info@gynetics.be
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