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Qoustic Wound Therapy System®, Model AR1000 Series
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Qoustic Wound Therapy System®, Model AR1000 Series FDA UDI
- Generic Name
- Soft-tissue ultrasonic surgical system FDA UDI
- Device Name
- Qoustic Wound Therapy System®, Model AR1000 Series - ultrasound wound therapy system for wound debridement and management FDA UDI
- Model / Reference
- AR1000 FDA UDI
- Description
- Qoustic Wound Therapy System®, Model AR1000 Series - ultrasound wound therapy system for wound debridement and management FDA UDI
Identifiers
- Catalog Number
- AR1000-SYS FDA UDI
- Primary DI / UDI-DI
- 00853077002008 FDA UDI
- FDA Product Code
- NRB FDA UDILFL 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
- 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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Weight — 23 Pound FDA UDIHeight — 12.25 Inch FDA UDIWidth — 19.5 Inch FDA UDIDepth — 20.625 Inch FDA UDI
Qoustic Wound Therapy System®, Model AR1000 Series by Arobella Medical, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K062544 also covers:
- Qoustic Choice® Wound Therapy System Converter Hand Piece — AROBELLA MEDICAL, LLC
- Qoustic Choice® Wound Therapy System Ultrasonic Generator — AROBELLA MEDICAL, LLC
- Qoustic Choice® Wound Therapy System, Disposable Tubing Set — AROBELLA MEDICAL, LLC
- Qoustic Choice® Wound Therapy System, Model AR1000D Series — AROBELLA MEDICAL, LLC
- Qoustic Wound Therapy System® Converter Hand Piece — AROBELLA MEDICAL, LLC
- Qoustic Wound Therapy System® Qoustic Key® — AROBELLA MEDICAL, LLC
- Qoustic Wound Therapy System® Ultrasonic Generator — AROBELLA MEDICAL, LLC
- Qoustic Wound Therapy System®, Cart, AR Series, Type 1, Base — AROBELLA MEDICAL, LLC
- Qoustic Wound Therapy System®, Cart, AR Series, Type 1, Support — AROBELLA MEDICAL, LLC
- Qoustic Wound Therapy System®, Model AR1000B Series — AROBELLA MEDICAL, LLC
- Qoustic Wound Therapy System®, Qoustic Qurette® Probe, Type 1 — AROBELLA MEDICAL, LLC
- Qoustic Wound Therapy System®, Qoustic Qurette® Probe, Type 11 — AROBELLA MEDICAL, LLC
K131096 also covers:
- Qoustic Choice® Wound Therapy System Converter Hand Piece — AROBELLA MEDICAL, LLC
- Qoustic Choice® Wound Therapy System Ultrasonic Generator — AROBELLA MEDICAL, LLC
- Qoustic Choice® Wound Therapy System, Disposable Tubing Set — AROBELLA MEDICAL, LLC
- Qoustic Choice® Wound Therapy System, Model AR1000D Series — AROBELLA MEDICAL, LLC
- Qoustic Wound Therapy System® Converter Hand Piece — AROBELLA MEDICAL, LLC
- Qoustic Wound Therapy System® Qoustic Key® — AROBELLA MEDICAL, LLC
- Qoustic Wound Therapy System® Ultrasonic Generator — AROBELLA MEDICAL, LLC
- Qoustic Wound Therapy System®, Cart, AR Series, Type 1, Base — AROBELLA MEDICAL, LLC
- Qoustic Wound Therapy System®, Cart, AR Series, Type 1, Support — AROBELLA MEDICAL, LLC
- Qoustic Wound Therapy System®, Model AR1000B Series — AROBELLA MEDICAL, LLC
- Qoustic Wound Therapy System®, Qoustic Qurette® Probe, Type 1 — AROBELLA MEDICAL, LLC
- Qoustic Wound Therapy System®, Qoustic Qurette® Probe, Type 11 — AROBELLA MEDICAL, LLC
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 18353640-2414-4f6d-b2ea-8f8d698285df 39 fields · synced May 31, 2026