Identity
- Trade Name
- Smart-Well Incubator FDA UDI
- Generic Name
- Biological sterilization indicator FDA UDI
- Device Name
- The Smart-Well Model 1710 EZTest Incubator is intended for use with the Smart-Read EZTest Steam self-contained biological indicator (SCBI). Each incubator cavity has an electronic monitoring system that detects if the BI is either purple or yellow. FDA UDI
- Model / Reference
- 1710 FDA UDI
- Description
- The Smart-Well Model 1710 EZTest Incubator is intended for use with the Smart-Read EZTest Steam self-contained biological indicator (SCBI). Each incubator cavity has an electronic monitoring system that detects if the BI is either purple or yellow. FDA UDI
Identifiers
- Catalog Number
- 999-028-999 FDA UDI
- Primary DI / UDI-DI
- M9859990280090 FDA UDI
- 510(k) Number
- K122362 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
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Biological sterilization indicator
Smart-Well Incubator 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 dcae3c5d-7b73-4a92-82f6-e3cafe2dcaf9 35 fields · synced May 29, 2026