FDA Registration
Active
🇺🇸 United States
Eagle1350 (NT) - TriMed EOS Small Bone Fixation System -Staples & Pins Nitinol Staple
Reg #: 1720929
·
FEI: 1720929
·
Expires 2025
Products
4
Proprietary Names
2
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- ISOMEDIX OPERATIONS INC.
- Registration Number
- 1720929
- FEI Number
- 1720929
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 9120 SOUTH 150 EAST
- City
- Sandy
- State
- UT
- ZIP
- 84070
- Country
- US
Regulatory Submissions
- 510(k) Number
- K112794
Owner / Operator
- Firm Name
- STERIS Corporation
- Operator Number
- 1527821
- Address
- 5960 Heisley Rd, --
- City
- Mentor
- State
- OH
- Postal Code
- 44060
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Staple, Fixation, Bone | JDR | Class 2 | Orthopedic | No | 2016-11-22 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2016-11-22 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2016-11-22 |
| Pin, Fixation, Smooth | HTY | Class 2 | Orthopedic | No | 2016-11-22 |
Proprietary Names
Eagle1350 (NT) - TriMed EOS Small Bone Fixation System -Staples & Pins Nitinol Staple
Eagle1350 (NT,SN) - Trimed Nitinol Staple System
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)