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MIST 360 Applicator

FDA UDI

Class II (US FDA UDI)

by Alliqua Biomedical, Inc.

Identity

Trade Name
MIST 360 Applicator FDA UDI
Generic Name
Wound therapy ultrasound system handpiece tip FDA UDI
Device Name
A sterile component of a wound therapy ultrasound system intended to be attached to the system treatment wand to interface low frequency ultrasound energy from the treatment wand with a fluid solution (e.g., saline) for the production of an ultrasound-conductive mist used to promote wound healing. it typically includes fluid delivery tubing and is intended to fit on the distal end of the treatment wand. This is a single-use device. FDA UDI
Model / Reference
CP-80024 FDA UDI
Description
A sterile component of a wound therapy ultrasound system intended to be attached to the system treatment wand to interface low frequency ultrasound energy from the treatment wand with a fluid solution (e.g., saline) for the production of an ultrasound-conductive mist used to promote wound healing. it typically includes fluid delivery tubing and is intended to fit on the distal end of the treatment wand. This is a single-use device. FDA UDI

Identifiers

Catalog Number
CP-80024 FDA UDI
Primary DI / UDI-DI
00816789010242 FDA UDI
510(k) Number
K122246 FDA UDI
FDA Product Code
NRB FDA UDI
GMDN Term
Wound therapy ultrasound system handpiece tip 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

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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Radiation Sterilization FDA UDI

Category: Wound therapy ultrasound system handpiece tip

MIST 360 Applicator by Alliqua Biomedical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Wound therapy ultrasound system handpiece tip.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Alliqua Biomedical, Inc.

Sources (1)

  • FDA UDI 6fb43518-26d6-45b3-a50b-72ab8eec94ce 37 fields · synced May 30, 2026