DEVICE: n.a. (04048551095027)

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Device Identifier (DI) Information

n.a.
26166V

Karl Storz GmbH & Co. KG
04048551095027
GS1
1
Vaginal plug
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Device Characteristics

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

GMDN

[?]

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

GMDN Preferred Term Name GMDN Definition
Polymeric vaginal stent, non-bioabsorbable A sterile non-bioabsorbable tubular device intended for long-term placement in the vagina to provide structural support and/or prevent shrinking. It is typically used for vaginal dilation following surgical or non-surgical treatment of vaginal agenesis or transgender vaginoplasty, or for the prevention of vaginal contracture or stenosis after radiotherapy. It is made of a synthetic polymer(s) [e.g., silicone] and may have various designs (e.g., inflatable tubular envelope with valves and internal drains, semi-soft moulded tube). This is a single-patient use device that can be reapplied to the patient during the treatment period (e.g., nightly) before being discarded (reusable).
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FDA Product Code

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Product Code Product Code Name
HIH HYSTEROSCOPE (AND ACCESSORIES)
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Sterilization

No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
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Storage and Handling

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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 Status

In Commercial Distribution
September 23, 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
No Package DIs found
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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)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
No
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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