DEVICE: Kitazato ET Catheter Type2-v1 EC-PRO Supported (04580303269541)
Device Identifier (DI) Information
Kitazato ET Catheter Type2-v1 EC-PRO Supported
215118 Type2-v1 EC-PRO Supported
In Commercial Distribution
215118
KITAZATO CORPORATION
215118 Type2-v1 EC-PRO Supported
In Commercial Distribution
215118
KITAZATO CORPORATION
4.7Fr 180mm EC-PRO Supported Inner Catheter and Outer Guide
Device Characteristics
Labeling does not contain MRI Safety Information | |
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? |
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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.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
MQF | CATHETER, ASSISTED REPRODUCTION |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K162878 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
52613562-2d87-4249-a200-218fbb256792
August 07, 2023
5
February 07, 2019
August 07, 2023
5
February 07, 2019
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
14580303269548 | 10 | 04580303269541 | 2023-01-18 | Not in Commercial Distribution |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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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