FDA Registration
Active
🇺🇸 United States
IntraMarX Radiopaque Markers
Reg #: 3016544248
·
FEI: 3016544248
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
4
Classifications
1
Registration Details
- Registration Name
- ANX ROBOTICA CORP.
- Registration Number
- 3016544248
- FEI Number
- 3016544248
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 6010 W. Spring Creek Pkwy
- City
- Plano
- State
- TX
- ZIP
- 75024
- Country
- US
Regulatory Submissions
- 510(k) Number
- K191087
Owner / Operator
- Firm Name
- AnX Robotica Corp.
- Operator Number
- 10062363
- Address
- 6010 W. Spring Creek Pkwy
- City
- Plano
- State
- TX
- Postal Code
- 75024
- Country
- US
- Correspondent
- Tim Thomas
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Gastrointestinal Motility (Electrical) | FFX | Class 2 | Gastroenterology, Urology | No | 2020-01-16 |
Proprietary Names
IntraMarX Radiopaque Markers
Establishment Types
Repack or Relabel Medical Device
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198