DEVICE: ALLURA (00650551002666)
Device Identifier (DI) Information
ALLURA
3321-212-T
In Commercial Distribution
PMT CORPORATION
3321-212-T
In Commercial Distribution
PMT CORPORATION
VAGINAL STENT, TAPERED CYLINDRICAL, SUTURE TABS, 4X12CM, 4CM PROJECTION, 115CC FILL
Device Characteristics
Labeling does not contain MRI Safety Information | |
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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? |
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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).
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Active | true |
FDA Product Code
[?]Product Code | Product Code Name |
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KXP | Stent, Vaginal |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K202542 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
277eb669-ce27-4813-a86c-d4b3ee3d1c32
September 28, 2021
1
September 20, 2021
September 28, 2021
1
September 20, 2021
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined