Identity
- Trade Name
- ENSURE Biological Indicators FDA UDI
- Generic Name
- Biological sterilization indicator FDA UDI
- Device Name
- Self-contained biological indicators for steam sterilization containing bacterial endospores of G. stearothermophilus. 100-count. FDA UDI
- Model / Reference
- SCI-BI100 FDA UDI
- Description
- Self-contained biological indicators for steam sterilization containing bacterial endospores of G. stearothermophilus. 100-count. FDA UDI
Identifiers
- Catalog Number
- SCI-BI100 FDA UDI
- Primary DI / UDI-DI
- 17540196000632 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
- 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
No
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
No
FDA UDI
Category: Biological sterilization indicator
ENSURE Biological Indicators by Scican GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Scican GmbH
Sources (1)
- FDA UDI 17a55b9d-07f2-4e3d-8ab3-09df3c48505d 36 fields · synced Jun 7, 2026