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Provox Measure

FDA UDI

Class I (US FDA UDI)

by Atos Medical Inc.

Identity

Trade Name
Provox Measure FDA UDI
Generic Name
Tracheoesophageal fistula gauge FDA UDI
Device Name
Provox Measure is intended for sizing the length (corresponding to voice prosthesis length) of tracheoesophageal (TE) punctures. FDA UDI
Model / Reference
7270 FDA UDI
Description
Provox Measure is intended for sizing the length (corresponding to voice prosthesis length) of tracheoesophageal (TE) punctures. FDA UDI

Identifiers

Catalog Number
7270 FDA UDI
Primary DI / UDI-DI
07331791001710 FDA UDI
FDA Product Code
LRC FDA UDI
GMDN Term
Tracheoesophageal fistula gauge FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
874.4420 FDA UDI
Commercial Distribution
Not 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
MRI Safety
MR Unsafe FDA UDI

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

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 c2a1be7a-ae47-43b2-aaed-db5b4260c18c 37 fields · synced May 30, 2026