DEVICE: Clear Shapeable Intrauterine Insemination catheter (M803TMI1297)
Device Identifier (DI) Information
Clear Shapeable Intrauterine Insemination catheter
Clear Shapeable Intrauterine Insemination catheter 23cm Box 25
In Commercial Distribution
TMI1297
MEDGYN PRODUCTS, INC.
Clear Shapeable Intrauterine Insemination catheter 23cm Box 25
In Commercial Distribution
TMI1297
MEDGYN PRODUCTS, INC.
Clear Shapeable Intrauterine Insemination catheter 23cm Box 25
Device Characteristics
MR Safe | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
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? |
---|---|---|---|---|
45846 | Assisted reproduction transfer catheter/set |
A device or collection of devices that includes a flexible polymer tube intended to be 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)]. In addition to the ‘live transfer’ catheter it may also include a trial transfer catheter intended to assess/ensure that embryo placement will be successful; it typically also includes devices intended to assist catheter introduction (e.g., outer guide sheath, stylet). This is a single-use device.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
MQF | Catheter, Assisted Reproduction |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
a0a3d514-3d08-40ef-bfb8-b83cdfdd6430
January 11, 2024
1
January 03, 2024
January 11, 2024
1
January 03, 2024
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
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
[?]
No Customer Contact currently defined