DEVICE: Stylet for Bulb Trans Ultra/ Bulb Trans Star Embryo Transfer Catheter - Bulb Tip (00812261016580)

Device Identifier (DI) Information

Stylet for Bulb Trans Ultra/ Bulb Trans Star Embryo Transfer Catheter - Bulb Tip
Stylet for Bulb Trans Ultra/ Bulb Trans Star Embryo Transfer Catheter
In Commercial Distribution
STY-BU
ALLWIN MEDICAL DEVICES, INC.
00812261016580
GS1

1
796354509 *Terms of Use
Stylet for Bulb Trans Ultra/ Bulb Trans Star Embryo Transfer Catheter - Bulb Tip
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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.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
MQF Catheter, Assisted Reproduction
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K200248 000
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Sterilization

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

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

839f57ea-e7e5-4e4a-b078-d4368103cba5
September 28, 2020
1
September 18, 2020
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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
10812261016587 10 00812261016580 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)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
Yes
No CLOSE

Customer Contact

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No Customer Contact currently defined
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