Identity
- Trade Name
- SIENTRA Vaginal Stent FDA UDI
- Generic Name
- Polymeric vaginal stent, non-bioabsorbable FDA UDI
- Device Name
- Vaginal Stent, Inflatable, 95 mm FDA UDI
- Model / Reference
- 3521-095U FDA UDI
- Description
- Vaginal Stent, Inflatable, 95 mm FDA UDI
Identifiers
- Catalog Number
- 3521-095U FDA UDI
- Primary DI / UDI-DI
- 00812790024919 FDA UDI
- 510(k) Number
- K974479 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
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 95 Millimeter FDA UDI
SIENTRA Vaginal Stent by Sientra, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Sientra, Inc.
Sources (1)
- FDA UDI a3c25182-210f-47fc-aa37-b9605a6a219a 38 fields · synced May 30, 2026