FDA Registration
Active
🇺🇸 United States
TRUE INDICATING LLC
Reg #: 3017524825
·
FEI: 3017524825
·
Expires 2026
Products
3
Proprietary Names
10
Establishment Types
2
Classifications
3
Registration Details
- Registration Name
- TRUE INDICATING LLC
- Registration Number
- 3017524825
- FEI Number
- 3017524825
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 946 Kane St, Suite A
- City
- Toledo
- State
- OH
- ZIP
- 43612
- Country
- US
Regulatory Submissions
- 510(k) Number
- K171823
Owner / Operator
- Firm Name
- True Indicating LLC
- Operator Number
- 10079928
- Address
- 946 Kane St, Suite A
- City
- Toledo
- State
- OH
- Postal Code
- 43612
- Country
- US
- Correspondent
- THOMAS J RIHA
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Indicator, Physical/Chemical Sterilization Process | JOJ | Class 2 | General Hospital | No | 2024-02-12 |
| Indicator, Biological Sterilization Process | FRC | Class 2 | General Hospital | No | 2021-01-04 |
| Indicator, Chemical, Enzymatic, Sterilization Process | MTC | Class 2 | General Hospital | No | 2021-12-17 |
Proprietary Names
Steam Indicating Autoclave Tape
True Indicating Self-Contained Biological Indicator
SBI-100
MSCS-05E
MSCST-05L
MSCST-05SF
SRI-050
Type 5 Integrating Indicator for Steam (CSPN-15)
Instant 20s Indicator
ISCS-05E
Establishment Types
Repack or Relabel Medical Device
Manufacture Medical Device