Identity
- Trade Name
- Sterrad FDA UDI
- Generic Name
- Biological sterilization indicator FDA UDI
- Device Name
- Sterrad 100NX International Validation Kit FDA UDI
- Model / Reference
- 20228 FDA UDI
- Description
- Sterrad 100NX International Validation Kit FDA UDI
Identifiers
- Catalog Number
- 20228 FDA UDI
- Primary DI / UDI-DI
- 10705037016495 FDA UDI
- GMDN Term
- Biological sterilization indicator FDA UDI
Classification
- 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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Sterilization packaging, single-useChemical/physical sterilization process indicatorBiological sterilization indicator
Sterrad by Advanced Sterilization Products Services Inc. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K071537 also covers:
K092755 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 | N/A | Pending data |
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Manufacturer
- Manufacturer
- Advanced Sterilization Products Services Inc.
Sources (1)
- FDA UDI 95134eb1-eaa5-44aa-9f65-a992a7a8acec 37 fields · synced May 30, 2026