Identity
- Trade Name
- Provox® Vega™ XtraSeal™ FDA UDI
- Generic Name
- Tracheoesophageal speech valve, indwelling FDA UDI
- Device Name
- Provox Vega voice prosthesis is an indwelling, low resistance voice prosthesis intended for voice restoration after surgical removal of the larynx. The prosthesis comes pre-loaded into the SmartInserter, ready for immediate insertion. The SmartInserter is a single-use replacement device intended for anterograde insertion only. Provox Vega XtraSeal has an additional enlarged esophageal flange that is intended to solve problems with leakage around the voice prosthesis. FDA UDI
- Model / Reference
- 22.5 Fr FDA UDI
- Description
- Provox Vega voice prosthesis is an indwelling, low resistance voice prosthesis intended for voice restoration after surgical removal of the larynx. The prosthesis comes pre-loaded into the SmartInserter, ready for immediate insertion. The SmartInserter is a single-use replacement device intended for anterograde insertion only. Provox Vega XtraSeal has an additional enlarged esophageal flange that is intended to solve problems with leakage around the voice prosthesis. FDA UDI
Identifiers
- Catalog Number
- 7785 FDA UDI
- Primary DI / UDI-DI
- 07331791010569 FDA UDI
- 510(k) Number
- K090455 FDA UDI
- FDA Product Code
- EWL FDA UDI
- GMDN Term
- Tracheoesophageal speech valve, indwelling FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.3730 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
Yes
FDA UDI
Combination Product
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Safe FDA UDI
Dimensions & Sizes
- Size
- Length — 10 Millimeter FDA UDI
Provox® Vega™ XtraSeal™ by Atos Medical Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K090455 also covers:
- Provox Vega 17Fr 10mm — ATOS MEDICAL INC.
- Provox Vega 17Fr 12.5mm — ATOS MEDICAL INC.
- Provox Vega 17Fr 15mm — ATOS MEDICAL INC.
- Provox Vega 17Fr 8mm — ATOS MEDICAL INC.
- Provox Vega 20Fr 10mm — ATOS MEDICAL INC.
- Provox Vega 20Fr 12.5mm — ATOS MEDICAL INC.
- Provox Vega 20Fr 15mm — ATOS MEDICAL INC.
- Provox Vega 20Fr 6mm — ATOS MEDICAL INC.
- Provox Vega 20Fr 8mm — ATOS MEDICAL INC.
- Provox Vega 22.5Fr 12.5mm — ATOS MEDICAL INC.
- Provox Vega 22.5Fr 15mm — ATOS MEDICAL INC.
- Provox Vega 22.5Fr 4mm — ATOS MEDICAL INC.
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
- Atos Medical Inc.
Sources (1)
- FDA UDI 18484fe7-b0bf-4c6a-aa60-a7a081e524a7 39 fields · synced Jun 1, 2026