DEVICE: Gynosampler (05425017500377)
Device Identifier (DI) Information
Gynosampler
#9164
In Commercial Distribution
Gynetics Medical Products NV
#9164
In Commercial Distribution
Gynetics Medical Products NV
The Gynosampler is an endometrial suction curette for a histologic lining biopsy.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No | |
Yes | |
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No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
11531 | 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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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
HFF | Aspirator, Endometrial |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K903002 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between 0 and 30 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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Outer Diameter: 2.93 Millimeter |
Length: 262 Millimeter |
Device Record Status
c96be6b0-7813-4653-b746-1c139e6f4b25
July 06, 2018
4
October 04, 2016
July 06, 2018
4
October 04, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]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 |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+3211645872
info@gynetics.be
info@gynetics.be