Identity
- Trade Name
- Spore Strip - EO/Dry Heat FDA UDI
- Generic Name
- Biological sterilization indicator FDA UDI
- Device Name
- Mesa Labs atrophaeus spore strip for Ethylene Oxide/Dry Heat - 10e6 FDA UDI
- Model / Reference
- 10e6 FDA UDI
- Description
- Mesa Labs atrophaeus spore strip for Ethylene Oxide/Dry Heat - 10e6 FDA UDI
Identifiers
- Catalog Number
- 1-1000 FDA UDI
- Primary DI / UDI-DI
- M985110001 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
Yes
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 Strip - EO/Dry Heat by Mesa Laboratories, Inc. — 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
- Mesa Laboratories, Inc.
Sources (1)
- FDA UDI c564a34f-db7a-4755-9344-2c300f25ef22 34 fields · synced Jun 8, 2026