UltraMIST Single Use Applicator

FDA UDI

Class II (US FDA UDI)

by SANUWAVE Health, Inc.

Identity

Trade Name: UltraMIST Single Use Applicator FDA UDI
Generic Name: Wound therapy ultrasound system FDA UDI
Device Name: Applicator fr UltraMIST (Wound Cleanser) FDA UDI
Model / Reference: AS-55057 FDA UDI
Description: Applicator fr UltraMIST (Wound Cleanser) FDA UDI

Identifiers

Primary DI / UDI-DI: 00812265010331 FDA UDI
510(k) Number: K140782 FDA UDI
FDA Product Code: NRB FDA UDI
GMDN Term: Wound therapy ultrasound system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 878.4410 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Wound therapy ultrasound system

UltraMIST Single Use Applicator by SANUWAVE Health, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Wound therapy ultrasound system.

UltraMIST Treatment Wand — SANUWAVE Health, Inc. · Class II
UltraMIST Single Use Applicator (12 Pack) — SANUWAVE Health, Inc. · Class II
UltraMIST Generator — SANUWAVE Health, Inc. · Class II

Cleared under the same submission

K140782 also covers:

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: SANUWAVE Health, Inc.

Sources (1)

FDA UDI 5dfcdd98-9702-4767-975d-897bbe4e0fb6 36 fields · synced May 30, 2026