DEVICE: Twinkle Embryo Trans Embryo Transfer Catheter (23cm) (00819374021524)
Device Identifier (DI) Information
Twinkle Embryo Trans Embryo Transfer Catheter (23cm)
Twinkle Embryo Trans (23cm)
In Commercial Distribution
TEB-ETC23
ALLWIN MEDICAL DEVICES, INC.
Twinkle Embryo Trans (23cm)
In Commercial Distribution
TEB-ETC23
ALLWIN MEDICAL DEVICES, INC.
Twinkle Embryo Trans Embryo Transfer Catheter 23cm
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? |
---|---|---|---|---|
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 [?] |
---|---|
K200248 | 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
a53bb1a0-8631-4906-95d7-deee5f1ef354
September 28, 2020
1
September 18, 2020
September 28, 2020
1
September 18, 2020
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
10819374021521 | 10 | 00819374021524 | 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
[?]
714-572-1709
info@allwinmedical.com
info@allwinmedical.com