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Provox Dilator

FDA UDI

Class I (US FDA UDI)

by Atos Medical Inc.

Identity

Trade Name
Provox Dilator FDA UDI
Generic Name
Tracheoesophageal fistula dilator, reusable FDA UDI
Device Name
The Provox Dilator is intended for upsizing smaller tracheo-esophageal (TE) punctures (i.e. from 16 Fr diameter) to allow fitting of Provox voice prostheses, or upsizing a shrunken puncture to an adequate diameter, i.e. after loss of a voice prosthesis. The dilator may also be used for temporary blockage of a TE puncture or to temporarily prevent such from shrinkage. It is only intended to be used by physicians or speech pathologists/therapists trained in the care and rehabilitation of laryngectomized. FDA UDI
Model / Reference
7211 FDA UDI
Description
The Provox Dilator is intended for upsizing smaller tracheo-esophageal (TE) punctures (i.e. from 16 Fr diameter) to allow fitting of Provox voice prostheses, or upsizing a shrunken puncture to an adequate diameter, i.e. after loss of a voice prosthesis. The dilator may also be used for temporary blockage of a TE puncture or to temporarily prevent such from shrinkage. It is only intended to be used by physicians or speech pathologists/therapists trained in the care and rehabilitation of laryngectomized. FDA UDI

Identifiers

Catalog Number
7211 FDA UDI
Primary DI / UDI-DI
07331791000850 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 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 a2e57116-ab19-4c34-8f03-8b17dc2bf1a2 36 fields · synced May 30, 2026