Identity
- Trade Name
- Single Species BI Strip FDA UDI
- Generic Name
- Biological sterilization indicator FDA UDI
- Device Name
- Bacillus atrophaeus 10e6 strip for EO Gas and Dry Heat sterilization processes FDA UDI
- Model / Reference
- BG-106 FDA UDI
- Description
- Bacillus atrophaeus 10e6 strip for EO Gas and Dry Heat sterilization processes FDA UDI
Identifiers
- Catalog Number
- BG-106 FDA UDI
- Primary DI / UDI-DI
- 10732224720439 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
Single Species BI Strip by Crosstex International, 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
- Crosstex International, Inc.
Sources (1)
- FDA UDI e0a3b067-9bdc-4eef-adc3-5b5c2af5a01b 36 fields · synced Jun 8, 2026