FDA UDI
In Commercial Distribution
🇺🇸 United States
LIBERTY Endovascular Robotic System - arm
DI: 07290019564102
·
Model: LIBERTYOS
·
MICROBOT MEDICAL LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- LIBERTY Endovascular Robotic System - arm
- Primary DI
- 07290019564102
- Version / Model
- LIBERTYOS
- Company Name
- MICROBOT MEDICAL LTD
- Labeler DUNS
- 649065489
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-11-18
- Public Version
- 1
- Public Version Date
- 2025-11-26
- Public Version Status
- New
- Public Device Record Key
- 76c12d00-ceb0-453a-af85-6efc27f0ff49
Device Description
LIBERTY Endovascular Robotic System - arm
Device Characteristics
- Single Use
- Yes
- 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 Conditional
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DXX | System, Catheter Control, Steerable | Cardiovascular | 870.1290 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 31742 | Cardiac mapping system workstation | A mains electricity (AC-powered) device designed as a control unit to percutaneously navigate (orientate and steer) a cardiac mapping system catheter, or its associated guidewire, in the desired direction to the designated target site (e.g., coronary vasculature). It uses dedicated software and may employ various technologies (often magnetic fields); it is typically used in the electrophysiology (EP) laboratory. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07290019564102 | GS1 |
Customer Contacts
- Phone
- 1-(888) 768-1664
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K243789 | 000 |
Storage Conditions
- Type
- Storage Environment Humidity
- Temperature Range
- 0 – 80 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- 4 – 37 Degrees Celsius