Identity
- Trade Name
- True Indicating FDA UDI
- Generic Name
- Biological sterilization indicator FDA UDI
- Device Name
- True Indicating Self-Contained Biological Indicator (SCBI) consists of a 6 mm filter paper disc inoculated with Geobacillus stearothermophilus ATCC® 7953, at a minimum of 105 bacterial spores encased within a polypropylene cap, and a polypropylene vial which includes a glass ampule hermetically sealed containing a nutrient broth culture medium modified with a pH indicator, Bromocresol Purple, sold as 25 units per box. For Use in Monitoring steam sterilization cycles at 121C, 30 minutes (Gravity), 132C, 4 minutes (Pre-Vacuum), and 135C, 3 minutes (Pre-Vacuum) FDA UDI
- Model / Reference
- MSCST-05-25 FDA UDI
- Description
- True Indicating Self-Contained Biological Indicator (SCBI) consists of a 6 mm filter paper disc inoculated with Geobacillus stearothermophilus ATCC® 7953, at a minimum of 105 bacterial spores encased within a polypropylene cap, and a polypropylene vial which includes a glass ampule hermetically sealed containing a nutrient broth culture medium modified with a pH indicator, Bromocresol Purple, sold as 25 units per box. For Use in Monitoring steam sterilization cycles at 121C, 30 minutes (Gravity), 132C, 4 minutes (Pre-Vacuum), and 135C, 3 minutes (Pre-Vacuum) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860011103486 FDA UDI
- 510(k) Number
- K200970 FDA UDI
- FDA Product Code
- FRC FDA UDI
- GMDN Term
- Biological sterilization indicator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.2800 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
True Indicating by True Indicating Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K200970 also covers:
- Approved — TRUE INDICATING LLC
- Excelsior Scientific — TRUE INDICATING LLC
- Larr-Test 24 — TRUE INDICATING LLC
- Larr-Test 24 — TRUE INDICATING LLC
- Larr-Test 24 — TRUE INDICATING LLC
- Sterim — TRUE INDICATING LLC
- Sterim — TRUE INDICATING LLC
- True Indicating — TRUE INDICATING LLC
- True Indicating — TRUE INDICATING LLC
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- True Indicating Llc
Sources (1)
- FDA UDI 301814df-afd9-4848-8430-61e8886311b3 36 fields · synced May 30, 2026