Identity
- Trade Name
- Provox Brush Long XL FDA UDI
- Generic Name
- Airway device cleaning utensil, invasive FDA UDI
- Device Name
- Provox Brush is a single patient use device intended for cleaning Provox voice prostheses, for insertion of Provox Plug and Provox Vega Plug, for applying lubricant and anti-candida agents and for cleaning of fenestration holes on Provox LaryTubes. The product is intended for use by the patient. FDA UDI
- Model / Reference
- 8425 FDA UDI
- Description
- Provox Brush is a single patient use device intended for cleaning Provox voice prostheses, for insertion of Provox Plug and Provox Vega Plug, for applying lubricant and anti-candida agents and for cleaning of fenestration holes on Provox LaryTubes. The product is intended for use by the patient. FDA UDI
Identifiers
- Catalog Number
- 8425 FDA UDI
- Primary DI / UDI-DI
- 07331791015595 FDA UDI
- FDA Product Code
- LRC FDA UDI
- GMDN Term
- Airway device cleaning utensil, invasive FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 874.4420 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
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Airway device cleaning utensil, invasive
Provox Brush Long XL by Atos Medical Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Atos Medical Inc.
Sources (2)
- FDA UDI 1a3049b4-857e-4928-a0da-00238d376cc9 36 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 18, 2026