Identity
- Trade Name
- Spore Check System FDA UDI
- Generic Name
- Biological sterilization indicator FDA UDI
- Device Name
- Biological Indicator FDA UDI
- Model / Reference
- Dual-Spore FDA UDI
- Description
- Biological Indicator FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00016724410001 FDA UDI
- 510(k) Number
- K905425 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
Spore Check System by Osha Review, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K905425 also covers:
- Dual Species BI Strip — CROSSTEX INTERNATIONAL, INC.
- Dual Species BI Strip — CROSSTEX INTERNATIONAL, INC.
- Dual Species BI Strip — CROSSTEX INTERNATIONAL, INC.
- Dual Species BI Strip — CROSSTEX INTERNATIONAL, INC.
- Dual Species BI Strip — CROSSTEX INTERNATIONAL, INC.
- Single Species BI Strip — CROSSTEX INTERNATIONAL, INC.
- Single Species BI Strip — CROSSTEX INTERNATIONAL, INC.
- Single Species BI Strip — CROSSTEX INTERNATIONAL, INC.
- Single Species BI Strip — CROSSTEX INTERNATIONAL, INC.
- Single Species BI Strip — CROSSTEX INTERNATIONAL, INC.
- Single Species BI Strip — CROSSTEX INTERNATIONAL, INC.
- Single Species BI Strip — CROSSTEX INTERNATIONAL, INC.
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Osha Review, Inc.
Sources (1)
- FDA UDI 261b3431-1869-4596-8606-0bc8e1e9d4b1 35 fields · synced May 30, 2026