Identity
- Trade Name
- Provox Vega Puncture Set 17Fr 15mm FDA UDI
- Generic Name
- Tracheoesophageal speech valve, indwelling FDA UDI
- Device Name
- The Provox Vega Puncture Set is a device for creating a primary or secondary TE puncture, with subsequent dilatation of that puncture to a width that facilitates placement of the included Provox Vega voice prosthesis. The Provox Vega voice prosthesis is preloaded on the Puncture Dilator, which is part of the device. The Provox Vega Puncture Set is intended for single use only. FDA UDI
- Model / Reference
- 8143US FDA UDI
- Description
- The Provox Vega Puncture Set is a device for creating a primary or secondary TE puncture, with subsequent dilatation of that puncture to a width that facilitates placement of the included Provox Vega voice prosthesis. The Provox Vega voice prosthesis is preloaded on the Puncture Dilator, which is part of the device. The Provox Vega Puncture Set is intended for single use only. FDA UDI
Identifiers
- Catalog Number
- 8143US FDA UDI
- Primary DI / UDI-DI
- 07331791009112 FDA UDI
- 510(k) Number
- K131947 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
- 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
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
Dimensions & Sizes
- Size
- Length — 15 Millimeter FDA UDI
Category: Tracheoesophageal speech valve, indwelling
Provox Vega Puncture Set 17Fr 15mm by Atos Medical Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Tracheoesophageal speech valve, indwelling.
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- InHealth Technologies — FREUDENBERG MEDICAL, LLC · Class II
- InHealth Technologies; Blom-Singer; Advantage — FREUDENBERG MEDICAL, LLC · Class II
- InHealth Technologies; Blom-Singer; Classic — FREUDENBERG MEDICAL, LLC · Class II
- InHealth Technologies — FREUDENBERG MEDICAL, LLC · Class II
- InHealth Technologies; Blom-Singer; Classic — FREUDENBERG MEDICAL, LLC · Class I
Cleared under the same submission
K131947 also covers:
- Provox Vega Puncture Set 17Fr 10mm — ATOS MEDICAL INC.
- Provox Vega Puncture Set 17Fr 12.5mm — ATOS MEDICAL INC.
- Provox Vega Puncture Set 17Fr 8mm — ATOS MEDICAL INC.
- Provox Vega Puncture Set 20Fr 10mm — ATOS MEDICAL INC.
- Provox Vega Puncture Set 20Fr 12.5mm — ATOS MEDICAL INC.
- Provox Vega Puncture Set 20Fr 8mm — ATOS MEDICAL INC.
- Provox Vega Puncture Set 22.5Fr 10mm — ATOS MEDICAL INC.
- Provox Vega Puncture Set 22.5Fr 12.5mm — ATOS MEDICAL INC.
- Provox Vega Puncture Set 22.5Fr 8mm — 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 871c7504-4c54-44ad-85a1-85a24539d273 38 fields · synced May 31, 2026