FDA Registration
Active
🇺🇸 United States
TZMed1418 (SN) - Pediatric Sterile Radiolucent Electrode
Reg #: 1720929
·
FEI: 1720929
·
Expires 2025
Products
1
Proprietary Names
5
Establishment Types
1
Classifications
1
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
- PMA Number
- P200005
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 |
|---|---|---|---|---|---|
| Automated External Defibrillators (Non-Wearable) | MKJ | Class 3 | Cardiovascular | No | 2024-09-11 |
Proprietary Names
TZMed1418 (SN) - Pediatric Sterile Radiolucent Electrode
TZMed1418 (SN) - Adult Sterile Radiolucent Electrode w/ Large Back Pad (Universal)
TZMed1418 (SN) - Adult Sterile Radiolucent Electrode w/ Large Back Pad (Zoll)
TZMed1418 (SN) - Adult Sterile Radiolucent Electrode (Universal)
TZMed1418 (SN) - Defib/Cardiovert/Pace/Monitoring Electrodes
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)