DEVICE: AVID TruCustom (10809160126196)

Device Identifier (DI) Information

AVID TruCustom
HSAM027-04_0001
In Commercial Distribution

AVID MEDICAL, INC.
10809160126196
GS1

1
015623119 *Terms of Use
No description.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
Yes
Yes
No
Yes
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Neovaginoplasty kit A collection of non-sterile devices intended to be used during laparoscopic-assisted creation of a neovagina in the treatment of vaginal aplasia, whereby creation/expansion of the vaginal cavity is achieved through implantation of a tensioning thread attached at one end to an extra-abdominal tensioning device, and at the other end to a vaginal dilator situated at the vagina/vaginal dimple. It typically includes thread implantation guides, vaginal dilator(s), and the tensioning device. Post-surgical, daily tensioning is intended to create the neovagina. This is a reusable device intended to be sterilized prior to use.
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FDA Product Code

[?]
Product Code Product Code Name
OKV Obstetrical kit
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

Yes
Yes
Sterilization Method [?]
Ethylene Oxide
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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

d0f10ef1-2bdb-4c6f-9b6a-d32750cc276f
March 29, 2018
2
February 06, 2017
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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
20809160126193 10 10809160126196 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

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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