FDA UDI
In Commercial Distribution
🇺🇸 United States
Focalist System
DI: 00850062065000
·
Model: C001-01
·
Mendaera, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Focalist System
- Primary DI
- 00850062065000
- Version / Model
- C001-01
- Company Name
- Mendaera, Inc.
- Labeler DUNS
- 100193165
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-08-11
- Public Version
- 1
- Public Version Date
- 2025-08-19
- Public Version Status
- New
- Public Device Record Key
- 15609849-d875-47f0-b2f6-d8a6de84ea88
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
- 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 |
|---|---|---|---|---|
| ITX | Transducer, Ultrasonic, Diagnostic | Radiology | 892.1570 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40971 | Ultrasound imaging system operator console | A device that is a component of a diagnostic ultrasound imaging system that functions as the primary control panel. It includes hardware and software that allows for image display, processing, analysis, archiving and retrieval. It typically includes the capabilities to be interfaced into a picture archiving and communication system (PACS), a local area network (LAN), a radiology information system (RIS) or a hospital information system (HIS). It contains the primary controls for the direct operation of the ultrasound system and is typically incorporated in the system design as is the case with mobile or portable ultrasound systems. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850062065000 | GS1 |
Customer Contacts
- Phone
- 1-877-636-3237
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K250524 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Weight | 75 | Kilogram |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -30 – 60 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 15 – 90 Percent (%) Relative Humidity