DEVICE: Soft embryo transfer catheter (05425017501077)

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Device Identifier (DI) Information

Soft embryo transfer catheter
#2000 Semtrac Set 4.2

Gynetics Medical Products NV
05425017501077
GS1
1
Embryo transfer catheter used for introduction of embryos into the uterine cavity.
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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
Assisted reproduction catheter set A collection of sterile devices used primarily to transfer gametes (eggs or sperm) and/or embryos into the female reproductive tract for the purpose of assisted reproduction [e.g., intrauterine insemination (IUI) or gamete intrafallopian transfer (GIFT)], a procedure that may be administered transvaginally or laparoscopically. It typically consists of a transfer catheter and an outer guide sheath, or an inner and outer catheter; a stylet may be included to aid passage through the cervix. Some sets may include a trial transfer catheter set to assess/ensure that embryo placement will be successful. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
MQF Catheter, Assisted Reproduction
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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
Total Volume: 0.23 Milliliter
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Device Status

In Commercial Distribution
October 14, 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
25425017501071 75 05425017501077 In Commercial Distribution
15425017501074 25 05425017501077 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

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+3211645872
info@gynetics.com
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