FDA Registration
Active
🇺🇸 United States
INNOVATIVE STERILIZATION TECHN
Reg #: 3010772758
·
FEI: 3010772758
·
Expires 2026
Products
1
Proprietary Names
6
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- INNOVATIVE STERILIZATION TECHN
- Registration Number
- 3010772758
- FEI Number
- 3010772758
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 7625 PARAGON RD STE A
- City
- Dayton
- State
- OH
- ZIP
- 45459
- Country
- US
Regulatory Submissions
- 510(k) Number
- K211007
Owner / Operator
- Firm Name
- Innovative Sterilization Technologies LLC
- Operator Number
- 10046120
- Address
- 7625 Paragon Rd, Suite A
- City
- Dayton
- State
- OH
- Postal Code
- 45459
- Country
- US
- Correspondent
- Scott E Cohen
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | Class 2 | General Hospital | No | 2026-02-02 |
Proprietary Names
EZ TRAX Persona Knee Containment Device
ONE TRAY
EZ TRAX Stryker Mako Total Knee Containment Device
ONE TRAY Sealed Sterilization Container System
EZ TRAX Zimmer G7 Acetabular Taperloc Complete Hip System Containment Device
EZ-TRAX Containment Device
Establishment Types
Manufacture Medical Device