DEVICE: Evie (07290016876024)

Device Identifier (DI) Information

Evie
EK002
In Commercial Distribution
EK002
FERTILIGENT LTD
07290016876024
GS1

1
533729471 *Terms of Use
Slow Release Insemination Catheter
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
Yes
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 A sterile flexible tube 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)]. The device may be administered transvaginally or laparoscopically. It is typically made of plastic materials such as polyethylene (PE), polytetrafluoroethylene (PTFE) commonly known as Teflon, polyurethane, or silicone, and is available in various lengths. 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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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Special Storage Condition, Specify: Keep dry
Special Storage Condition, Specify: Keep away from sunlight
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

01bdbb34-6781-460a-801a-5927dd3de015
March 29, 2018
2
November 09, 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
17290016876021 3 07290016876024 In Commercial Distribution Box
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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

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Yes
No
Yes
Yes
No CLOSE

Customer Contact

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No Customer Contact currently defined
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