FDA Registration
Active
🇺🇸 United States
EZ-TRAX
Reg #: 3021119558
·
FEI: 3021119558
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Assembly-Tek LLC
- Registration Number
- 3021119558
- FEI Number
- 3021119558
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 295 S Alex Rd
- City
- Dayton
- State
- OH
- ZIP
- 45449
- Country
- US
Regulatory Submissions
- 510(k) Number
- K192487
Owner / Operator
- Firm Name
- Assembly-Tek LLC
- Operator Number
- 10083684
- Address
- 295 S. Alex
- City
- West Carrollton
- State
- OH
- Postal Code
- 45449
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | Class 2 | General Hospital | No | 2024-07-23 |
Proprietary Names
EZ-TRAX
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)