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Provox Dilator 17

FDA UDI

Class I (US FDA UDI)

by Atos Medical Inc.

Identity

Trade Name
Provox Dilator 17 FDA UDI
Generic Name
Tracheoesophageal fistula dilator, reusable FDA UDI
Device Name
The Provox voice prosthesis system is intended for use of prosthetic voice restoration after total laryngectomy. The Provox Dilator 17 and 20 are used for dilating tracheo-esophageal (TE) punctures that shrinks very fast or are too narrow to insert the selected Provox voice prosthesis. The Dilator may also be used to temporarily block or stent the TE puncture. FDA UDI
Model / Reference
7122 FDA UDI
Description
The Provox voice prosthesis system is intended for use of prosthetic voice restoration after total laryngectomy. The Provox Dilator 17 and 20 are used for dilating tracheo-esophageal (TE) punctures that shrinks very fast or are too narrow to insert the selected Provox voice prosthesis. The Dilator may also be used to temporarily block or stent the TE puncture. FDA UDI

Identifiers

Catalog Number
7122 FDA UDI
Primary DI / UDI-DI
07331791000393 FDA UDI
FDA Product Code
LRC FDA UDI
GMDN Term
Tracheoesophageal fistula dilator, reusable 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

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Tracheoesophageal fistula dilator, reusable

Provox Dilator 17 by Atos Medical Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Tracheoesophageal fistula dilator, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Atos Medical Inc.

Sources (1)

  • FDA UDI c18f0ba0-4dc4-43d0-b371-eb3c382047c1 36 fields · synced May 30, 2026