Identity
- Trade Name
- ULTRA GI Cycle Validation Kit FDA UDI
- Generic Name
- Instrument tray, reusable FDA UDI
- Device Name
- STERRAD 100NX System ULTRA GI Cycle Validation Kit FDA UDI
- Model / Reference
- 43380 FDA UDI
- Description
- STERRAD 100NX System ULTRA GI Cycle Validation Kit FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10705037069583 FDA UDI
- FDA Product Code
- FRG FDA UDIFRC FDA UDI
- GMDN Term
- Instrument tray, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.6850 FDA UDI880.2800 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
Yes
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: Instrument tray, reusableBiological sterilization indicator
ULTRA GI Cycle Validation Kit by Advanced Sterilization Products Services Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K234082 also covers:
- Aptimax Instrument TRAY for ULTRA GI Cycle — ADVANCED STERILIZATION PRODUCTS SERVICES INC.
- STERRAD 100NX with ALLCLEAR Technology And ULTRA GI cyle — ADVANCED STERILIZATION PRODUCTS SERVICES INC.
- STERRAD 100NX with ALLCLEAR Technology And ULTRA GI cyle — ADVANCED STERILIZATION PRODUCTS SERVICES INC.
- Sterrad — ADVANCED STERILIZATION PRODUCTS SERVICES INC.
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 Process Challenge Device (PCD) Vial — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Advanced Sterilization Products Services Inc.
Sources (1)
- FDA UDI e8cf56f1-e498-4de7-ab2a-98e6b238eb1b 35 fields · synced May 30, 2026