Provox LaryButton Sizer Kit

FDA UDI

Class I (US FDA UDI)

by Atos Medical Inc.

Identity

Trade Name: Provox LaryButton Sizer Kit FDA UDI
Generic Name: Tracheostoma button FDA UDI
Device Name: The Provox LaryButton Sizer Kit is intended for use by the prescribing clinician to determine the size(s) of LaryButton that should be prescribed to the patient. The Sizer Kit should be used only by a prescribing clinician who has read the LaryButton Manual. A copy of that manual comes with the Sizer Kit. It can also be viewed on the Internet at www.atosmedical.com. The Sizer LaryButtons are intended for the sizing procedure only. After the correct size(s) have been determined a new LaryButton(s) shall be prescribed to the patient for actual use. FDA UDI
Model / Reference: 7690 FDA UDI
Description: The Provox LaryButton Sizer Kit is intended for use by the prescribing clinician to determine the size(s) of LaryButton that should be prescribed to the patient. The Sizer Kit should be used only by a prescribing clinician who has read the LaryButton Manual. A copy of that manual comes with the Sizer Kit. It can also be viewed on the Internet at www.atosmedical.com. The Sizer LaryButtons are intended for the sizing procedure only. After the correct size(s) have been determined a new LaryButton(s) shall be prescribed to the patient for actual use. FDA UDI

Identifiers

Catalog Number: 7690 FDA UDI
Primary DI / UDI-DI: 07331791002779 FDA UDI
FDA Product Code: KAC FDA UDI
GMDN Term: Tracheostoma button 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

MRI Safety

MR Safe FDA UDI

Category: Tracheostoma button

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

Similar devices

Also classified as Tracheostoma button.

Montgomery® Short-Term Cannula — Boston Medical Products, Inc. · Class II
Montgomery® Initial Cannula Set — Boston Medical Products, Inc. · Class II
Bivona — ICU MEDICAL, INC. · Class II
Montgomery® Initial Cannula Set — Boston Medical Products, Inc. · Class II
Montgomery® Long-Term Cannula — Boston Medical Products, Inc. · Class II
Montgomery® Long-Term Cannula — Boston Medical Products, Inc. · Class II
Montgomery® Short-Term Cannula — Boston Medical Products, Inc. · Class II
Montgomery® Long-Term Cannula — Boston Medical Products, Inc. · Class II

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 I	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Atos Medical Inc.

Sources (1)

FDA UDI 11462e8a-8111-4046-8688-94845f7b6dbc 36 fields · synced Jun 8, 2026