Identity
- Trade Name
- Provox GuideWire FDA UDI
- Generic Name
- Tracheoesophageal speech valve guidewire FDA UDI
- Device Name
- The Provox GuideWire is a sterile, single use insertion device intended for placement of a sterile Provox indwelling voice prosthesis after total laryngectomy (primary or secondary puncture), or for retrograde replacement of a sterile Provox indwelling voice prosthesis. FDA UDI
- Model / Reference
- 7215 FDA UDI
- Description
- The Provox GuideWire is a sterile, single use insertion device intended for placement of a sterile Provox indwelling voice prosthesis after total laryngectomy (primary or secondary puncture), or for retrograde replacement of a sterile Provox indwelling voice prosthesis. FDA UDI
Identifiers
- Catalog Number
- 7215 FDA UDI
- Primary DI / UDI-DI
- 07331791000867 FDA UDI
- 510(k) Number
- K940638 FDA UDI
- FDA Product Code
- EWL FDA UDI
- GMDN Term
- Tracheoesophageal speech valve guidewire 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
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Tracheoesophageal speech valve guidewire
Provox GuideWire 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 d8097889-cab3-4b21-a44c-fc2ac23f5767 37 fields · synced May 30, 2026