DEVICE: ALLURA (00650551002666)

Device Identifier (DI) Information

ALLURA
3321-212-T
In Commercial Distribution

PMT CORPORATION
00650551002666
GS1

1
039576871 *Terms of Use
VAGINAL STENT, TAPERED CYLINDRICAL, SUTURE TABS, 4X12CM, 4CM PROJECTION, 115CC FILL
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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?
51084 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).
Active true
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FDA Product Code

[?]
Product Code Product Code Name
KXP Stent, Vaginal
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K202542 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

[?]
Size Type Text
No Device Sizes
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Device Record Status

277eb669-ce27-4813-a86c-d4b3ee3d1c32
September 28, 2021
1
September 20, 2021
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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
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)

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

[?]
Yes
Yes
Yes
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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