Qoustic Choice® Wound Therapy System Converter Hand Piece AR1000D-H/P
GUDID 00853077002145
Hand Piece, Converter, Qoustic Choice® Wound Therapy System, Model AR1000D Series
AROBELLA MEDICAL, LLC
Soft-tissue ultrasonic surgical system handpiece, reusable| Primary Device ID | 00853077002145 |
| NIH Device Record Key | 3f97fa25-8c75-498e-aa68-9cd9d53768b1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Qoustic Choice® Wound Therapy System Converter Hand Piece |
| Version Model Number | AR1000D |
| Catalog Number | AR1000D-H/P |
| Company DUNS | 839978876 |
| Company Name | AROBELLA MEDICAL, LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 952-288-2810 |
| lyoshikawa@arobella.com |
Device Dimensions
| Depth | 12 Inch |
| Depth | 12 Inch |
| Depth | 12 Inch |
| Depth | 12 Inch |
Operating and Storage Conditions
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00853077002145 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K062544
FDA Product Code
| NRB | Wound Cleaner, Ultrasound |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00853077002145]
Liquid Chemical;Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-08-06 |
| Device Publish Date | 2017-03-01 |
Devices Manufactured by AROBELLA MEDICAL, LLC
| 00853077002220 - Qoustic Wound Therapy System® Ultrasonic Generator | 2018-09-24 Ultrasonic Generator, Qoustic Wound Therapy System®, Model AR1000 Series |
| 00853077002237 - Qoustic Wound Therapy System® Ultrasonic Generator | 2018-09-24 Ultrasonic Generator, Qoustic Wound Therapy System®, Model AR1000B Series |
| 00853077002244 - Qoustic Choice® Wound Therapy System Ultrasonic Generator | 2018-09-24 Ultrasonic Generator, Qoustic Choice® Wound Therapy System, Model AR1000D Series |
| 00853077002008 - Qoustic Wound Therapy System®, Model AR1000 Series | 2018-08-06 Qoustic Wound Therapy System®, Model AR1000 Series - ultrasound wound therapy system for wound debridement and management |
| 00853077002015 - Qoustic Wound Therapy System® Converter Hand Piece | 2018-08-06 Hand Piece, Converter, Qoustic Wound Therapy System®, Model AR1000 Series |
| 00853077002022 - Qoustic Wound Therapy System®, Cart, AR Series, Type 1, Support | 2018-08-06 Support, Cart, AR Series, Type 1, Qoustic Wound Therapy System®, Model AR1000 Series |
| 00853077002039 - Qoustic Wound Therapy System®, Cart, AR Series, Type 1, Base | 2018-08-06 Base, Cart, AR Series, Type 1, Qoustic Wound Therapy System®, Model AR1000 Series |
| 00853077002060 - Qoustic Wound Therapy System®, Qoustic Qurette® Probe, Type 1 | 2018-08-06 Qoustic Wound Therapy System®, Qoustic Qurette® Probe, Type 1 + Qoustic Qurette® Shroud, Type P |
Trademark Results [Qoustic Choice]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 QOUSTIC CHOICE 77583273 not registered Dead/Abandoned |
Arobella Medical, LLC 2008-10-01 |
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