FDA UDI
In Commercial Distribution
🇺🇸 United States
SonoScape
DI: 06945868601713
·
Model: MPTEE mini
·
SONOSCAPE MEDICAL CORP.
Product Codes
3
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- SonoScape
- Primary DI
- 06945868601713
- Version / Model
- MPTEE mini
- Company Name
- SONOSCAPE MEDICAL CORP.
- Labeler DUNS
- 545342185
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-19
- Public Version
- 4
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- ea354b20-0947-44bf-945d-8a08ecd113f3
Device Description
MPTEE mini Ultrasonic Transducer (S9)
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
- No
- 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 |
|---|---|---|---|---|
| ITX | Transducer, Ultrasonic, Diagnostic | Radiology | 892.1570 | 2 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | Radiology | 892.1560 | 2 |
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | Radiology | 892.1550 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37891 | Oesophageal ultrasound imaging transducer, reusable | An ultrasound imaging transducer assembly enclosed in a fluid-resistant, acoustically- and electrically-insulated housing, designed to be inserted and positioned in the oesophagus to obtain ultrasound images of the heart and/or to navigate devices requiring ultrasound guidance and placement (e.g., endoscopy equipment or needle biopsy equipment). Also known as an oesophageal endosonography probe or transducer, it is composed of either a single transducer element or an array of transducer elements, i.e., piezoelectric element(s), active element(s), or crystal(s), and associated damping, backing, and matching layer materials. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06945868601713 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K152165 | 000 |