Facility
INNOVATIVE STERILIZATION TECHN
1 recall(s) on record — most severe on record: Class II.
| FDA Establishment Identifier (FEI) | 3010772758 |
|---|---|
| Establishment type | Manufacture Medical Device |
| Location | 7625 PARAGON RD STE A Dayton, OH, US 45459 |
| Registration status | Active · expires 2026 |
| Parent company | Innovative Sterilization Technologies LLC (owner-operator 10046120) |
| Brand names | ONE TRAY Sealed Sterilization Container System |
Devices registered here (1)
- Sterilization Wrap Containers, Trays, Cassettes & Other AccessoriesProduct code KCT · Class II · General Hospital · 21 CFR 880.6850
Recalls & enforcement
- Class IITerminated2014-02-03The wrong sterilization time was on the label. The label lists Steam Gravity 10 - 34 minutes at 270 degrees F instead of Steam Gravity 17 - 34 minutes at 270 degrees F.
Related
Source: U.S. FDA via openFDA (device registration & enforcement). Data as of 2026-08-13. Verify this facility record at FDA →
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