DEVICE: Amielle cone size 4 (00384702105011)

Device Identifier (DI) Information

Amielle cone size 4
SM 2105
In Commercial Distribution
SM 2105
OWEN MUMFORD USA INCORPORATED
00384702105011
GS1

1
803401454 *Terms of Use
Amielle is intended to be inserted into the vagina and progressively dilate the vagina.
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Device Characteristics

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

GMDN

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

GMDN Preferred Term Name GMDN Definition
Vaginal dilator A firm rod-like instrument designed to mechanically enlarge the vagina during examination, treatment, and/or during surgical procedures. It can also be inserted into the vagina and worn for prescribed periods to maintain vaginal patency after surgery (e.g., transgender vaginoplasty) or radiation treatments, or to stretch the vaginal orifice (the introitus) when it is unusually narrow due to a birth defect or vaginismus (the inability of the vaginal sphincter to relax). The device is typically available in a set of graduated sizes and the user is typically instructed to begin with the smallest diameter, increasing in size until satisfactory patency is achieved. This is a reusable device.
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FDA Product Code

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Product Code Product Code Name
KXP Stent, Vaginal
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K983045 000
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Sterilization

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

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Storage and Handling
Storage Environment Temperature: between 5 and 40 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
Length: 160 Millimeter
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Device Record Status

0a21dd55-8654-4f68-9541-f31ec6d4f088
July 06, 2018
3
September 19, 2016
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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
00384702105035 20 00384702105011 In Commercial Distribution Case
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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

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Yes
No
No
Yes
No CLOSE

Customer Contact

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770-977-2226
info@owenmumfordinc.com
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