Identity
- Trade Name
- ULTRA GI Process Challenge Device (PCD) Vial FDA UDI
- Generic Name
- Biological sterilization indicator FDA UDI
- Device Name
- ULTRA GI Cycle Process Challenge Device Vial FDA UDI
- Model / Reference
- 43400 FDA UDI
- Description
- ULTRA GI Cycle Process Challenge Device Vial FDA UDI
Identifiers
- Primary DI / UDI-DI
- 20705037069368 FDA UDI
- 510(k) Number
- K234084 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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Biological sterilization indicator
ULTRA GI Process Challenge Device (PCD) Vial by Advanced Sterilization Products Services Inc. — Class II — FDA UDI — listed in FDA GUDID
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Cleared under the same submission
K234084 also covers:
- STERRAD — ADVANCED STERILIZATION PRODUCTS SERVICES INC.
- STERRAD — ADVANCED STERILIZATION PRODUCTS SERVICES INC.
- STERRAD — ADVANCED STERILIZATION PRODUCTS SERVICES INC.
- STERRAD SEALSURE — ADVANCED STERILIZATION PRODUCTS SERVICES INC.
- ULTRA GI Cycle Validation Kit — ADVANCED STERILIZATION PRODUCTS SERVICES 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 |
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Manufacturer
- Manufacturer
- Advanced Sterilization Products Services Inc.
Sources (1)
- FDA UDI 99e80732-43b7-4f91-be87-7cc2d8696ffc 35 fields · synced May 30, 2026