Identity
- Trade Name
- ALLURA FDA UDI
- Generic Name
- Polymeric vaginal stent, non-bioabsorbable FDA UDI
- Device Name
- ALLURA STENT STYLET - 8CM FDA UDI
- Model / Reference
- 3333-08 FDA UDI
- Description
- ALLURA STENT STYLET - 8CM FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00650551002239 FDA UDI
- 510(k) Number
- K202542 FDA UDI
- FDA Product Code
- KXP FDA UDI
- GMDN Term
- Polymeric vaginal stent, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.3900 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Polymeric vaginal stent, non-bioabsorbable
Allura by Pmt Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Polymeric vaginal stent, non-bioabsorbable.
Cleared under the same submission
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Pmt Corp.
Sources (1)
- FDA UDI 83c194bd-cc7a-4435-9efa-8efa174fdd39 34 fields · synced May 30, 2026