Identity
- Trade Name
- VERIFY FDA UDI
- Generic Name
- Biological sterilization indicator FDA UDI
- Device Name
- The VERIFY Disposable Biological Steam Test Pack is a single use test pack designed for monitoring the effectiveness of common steam sterilizing processes, including 250 degrees F (121 degrees C) gravity cycles and 270 degrees F (132 C) prevacuum cycles. 20 Packs with 5 Controls. FDA UDI
- Model / Reference
- S3065 FDA UDI
- Description
- The VERIFY Disposable Biological Steam Test Pack is a single use test pack designed for monitoring the effectiveness of common steam sterilizing processes, including 250 degrees F (121 degrees C) gravity cycles and 270 degrees F (132 C) prevacuum cycles. 20 Packs with 5 Controls. FDA UDI
Identifiers
- Catalog Number
- S3065 FDA UDI
- Primary DI / UDI-DI
- 10724995220300 FDA UDI
- 510(k) Number
- K854902 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
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Biological sterilization indicator
Verify by Steris Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K854902 also covers:
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
- Steris Corporation
Sources (1)
- FDA UDI 2089aed7-8ad9-4795-95c8-8640ef506981 37 fields · synced Jun 8, 2026