High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Mist
OUJ is the FDA product code for High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Mist, a class II device type, regulated under 21 CFR 892.1570. FDA's definition for this code reads: "To provide high level disinfection of ultrasound transducers. If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf)". As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and one recall.
Classification record
- Product code
- OUJ
- Device name
- High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers, Mist
- FDA definition
- To provide high level disinfection of ultrasound transducers. If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
- Regulation
- 21 CFR 892.1570
- Device class
- Class II
- Review panel
- Radiology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- Yes
- Ingested clearances
- 4
- Ingested recalls
- 1
Clearances, product code OUJ
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2011 | 1 |
| 2018 | 1 |
| 2024 | 1 |
| 2025 | 1 |
Applicants with the most clearances
Product code OUJ| Applicant | Clearances |
|---|---|
| Nanosonics Limited | 4 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
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