FDA UDI
In Commercial Distribution
🇺🇸 United States
MEDISONO
DI: B369MUS05250
·
Model: LINEAR ARRAY PROBE MODEL PB-9L-A FOR MEDISONO MS12
·
Medisono, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- MEDISONO
- Primary DI
- B369MUS05250
- Version / Model
- LINEAR ARRAY PROBE MODEL PB-9L-A FOR MEDISONO MS12
- Company Name
- Medisono, LLC
- Labeler DUNS
- 079686615
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-01-24
- Public Version
- 2
- Public Version Date
- 2026-03-23
- Public Version Status
- Update
- Public Device Record Key
- 4c23c531-bbee-4b5d-b207-2a6927269ab9
Device Description
Probe
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- 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 |
|---|---|---|---|---|
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | Radiology | 892.1550 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40761 | General-purpose ultrasound imaging system | A stationary or mobile (e.g., on wheels) assembly of devices designed to collect, display, and analyse ultrasound images during a variety of extracorporeal and/or intracorporeal (endosonography or endoscopic) ultrasound imaging procedures (e.g., cardiac, OB/GYN, endoscopy, breast, prostate, vascular, and intra-surgical imaging). It consists of a mains (AC-powered) data processing unit with integrated software and a monitor. It is typically presented as a mobile assembly which may support a wide variety of transducers and related application software packages; an ultrasound transducer(s) may be included. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B369MUS05250 | HIBCC |
Customer Contacts
- Phone
- +13054063931
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K170303 | 000 |