FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Sonon
DI: 00860000879835
·
Model: 300L
·
Healcerion Co., Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Sonon
- Primary DI
- 00860000879835
- Version / Model
- 300L
- Catalog Number
- 300L
- Company Name
- Healcerion Co., Ltd.
- Labeler DUNS
- 688732988
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-01-21
- Public Version
- 3
- Public Version Date
- 2021-06-21
- Public Version Status
- Update
- Public Device Record Key
- 808ce641-27f0-4693-8fbc-704b795332af
- Distribution End Date
- 2021-06-21
Device Description
System, Imaging, Pulsed Doppler, Ultrasonic
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | Radiology | 892.1560 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40767 | Extracorporeal ultrasound imaging transducer, mounted | An ultrasound imaging transducer assembly that is either located within the housing of an ultrasound based scanner system, e.g., a breast scanning system, Doppler flow system, ultrasound based bone absorptiometry or densitometry system; or is mounted on a floor, wall or ceiling suspension allowing the operator to position the transducer assembly outside of the patient's body. Included is a variety of single or multiple element transducer assembly configurations that convert electric voltages into an ultrasound beam. It steers, focuses and detects the ultrasound beam and resulting echoes either mechanically or electronically. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860000879835 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K170085 | 000 |