Identity
- Trade Name
- Provox Vega Plug 17 FDA UDI
- Generic Name
- Tracheoesophageal speech valve occluder, non-valved FDA UDI
- Device Name
- The Provox Vega Plug is a first-aid tool for temporarily stopping leakage through a Provox Vega voice prosthesis. The device is inserted into the opening of the Provox Vega voice prosthesis and hence blocking any leakage through the valve. FDA UDI
- Model / Reference
- 8119 FDA UDI
- Description
- The Provox Vega Plug is a first-aid tool for temporarily stopping leakage through a Provox Vega voice prosthesis. The device is inserted into the opening of the Provox Vega voice prosthesis and hence blocking any leakage through the valve. FDA UDI
Identifiers
- Catalog Number
- 8119 FDA UDI
- Primary DI / UDI-DI
- 07331791005947 FDA UDI
- 510(k) Number
- K940638 FDA UDI
- FDA Product Code
- EWL FDA UDI
- GMDN Term
- Tracheoesophageal speech valve occluder, non-valved FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.3730 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
Yes
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Tracheoesophageal speech valve occluder, non-valved
Provox Vega Plug 17 by Atos Medical Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Atos Medical Inc.
Sources (1)
- FDA UDI 344a63b2-dab7-4191-9f32-563345a21ecb 38 fields · synced May 30, 2026