FDA Registration
Active
🇺🇸 United States
Spirol Block Catheter
Reg #: 1316297
·
FEI: 1316297
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
3
Classifications
1
Registration Details
- Registration Name
- EPIMED INTERNATIONAL, INC.
- Registration Number
- 1316297
- FEI Number
- 1316297
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 141 SAL LANDRIO DR., CROSSROADS BUSINESS PARK
- City
- JOHNSTOWN
- State
- NY
- ZIP
- 12095
- Country
- US
Regulatory Submissions
- 510(k) Number
- K133316
Owner / Operator
- Firm Name
- Epimed International, Inc.
- Operator Number
- 1316297
- Address
- 141 SAL LANDRIO DR., CROSSROADS BUSINESS PARK
- City
- Johnstown
- State
- NY
- Postal Code
- 12095
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Catheter, Conduction, Anesthetic | BSO | Class 2 | Anesthesiology | No | 2014-12-29 |
Proprietary Names
Spirol Block Catheter
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device