DEVICE: Wallace (15019315056680)

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Device Record History
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Device Identifier (DI) Information
Wallace
PPB623
In Commercial Distribution

ICU MEDICAL, INC.
15019315056680
GS1

1
118380146 *Terms of Use
No description.
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Device Characteristics
Labeling does not contain MRI Safety Information
No
Yes
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?
41438 Assisted reproduction catheter set
A collection of sterile devices 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)], a procedure that may be administered transvaginally or laparoscopically. It typically consists of a transfer catheter and an outer guide sheath, or an inner and outer catheter; a stylet may be included to aid passage through the cervix. Some sets may include a trial transfer catheter set to assess/ensure that embryo placement will be successful. This is a single-use device.
Obsolete 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 [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

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

[?]
Size Type Text
No Device Sizes
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Device Record Status
9bc5b849-d762-4b57-83bc-a7a205185cf2
April 17, 2025
3
December 07, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
35019315056684 10 15019315056680 In Commercial Distribution BOX
55019315056688 100 35019315056684 In Commercial Distribution CARTON
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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

[?]
No Customer Contact currently defined
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