Qoustic Wound Therapy System®, Qoustic Qurette® Probe, Type 12

FDA UDI

Class II (US FDA UDI)

by Arobella Medical, Llc

Identity

Trade Name: Qoustic Wound Therapy System®, Qoustic Qurette® Probe, Type 12 FDA UDI
Generic Name: Soft-tissue ultrasonic surgical system FDA UDI
Device Name: Qoustic Wound Therapy System®, Qoustic Qurette® Probe, Type 12 + Qoustic Qurette® Shroud, Type PWD FDA UDI
Model / Reference: AR1000D FDA UDI
Description: Qoustic Wound Therapy System®, Qoustic Qurette® Probe, Type 12 + Qoustic Qurette® Shroud, Type PWD FDA UDI

Identifiers

Catalog Number: AR1000D-QT12 FDA UDI
Primary DI / UDI-DI: 00853077002169 FDA UDI
510(k) Number: K062544 FDA UDI
K131096 FDA UDI
FDA Product Code: NRB FDA UDI
LFL FDA UDI
GMDN Term: Soft-tissue ultrasonic surgical 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

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

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

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size: Weight — 1 Pound FDA UDI
Height — 2.3 Inch FDA UDI
Width — 5.3 Inch FDA UDI
Depth — 6 Inch FDA UDI
Outer Diameter — 3.6 Millimeter FDA UDI

Category: Soft-tissue ultrasonic surgical system

Qoustic Wound Therapy System®, Qoustic Qurette® Probe, Type 12 by Arobella Medical, Llc — Class II — FDA UDI — listed in FDA GUDID

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Cleared under the same submission

K062544 also covers:

K131096 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: Arobella Medical, Llc

Sources (1)

FDA UDI 74aac67a-fb59-4aef-86ba-e70f4317175a 38 fields · synced May 30, 2026