Identity
- Trade Name
- Provox Plug FDA UDI
- Generic Name
- Tracheoesophageal speech valve occluder, non-valved FDA UDI
- Device Name
- The Provox Plug is a first-aid tool for temporarily stopping leakage through the voice prosthesis. The device is inserted into the opening of the Provox voice prosthesis. The medallion end can be taped to the skin if desired. FDA UDI
- Model / Reference
- 7205 FDA UDI
- Description
- The Provox Plug is a first-aid tool for temporarily stopping leakage through the voice prosthesis. The device is inserted into the opening of the Provox voice prosthesis. The medallion end can be taped to the skin if desired. FDA UDI
Identifiers
- Catalog Number
- 7205 FDA UDI
- Primary DI / UDI-DI
- 07331791000782 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 Plug 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 84e4afec-75b8-498a-8d1b-ef9b0a81cf56 38 fields · synced May 30, 2026