Identity
- Trade Name
- STERRAD NX™ Cassette EUDAMEDSterrad FDA UDI
- Generic Name
- Hydrogen peroxide device sterilant FDA UDI
- Device Name
- STERRAD NX™ Cassette EUDAMEDSterrad NX Cassette FDA UDI
- Model / Reference
- 10133 EUDAMEDFDA UDI
- Description
- Sterrad NX Cassette FDA UDI
Identifiers
- Catalog Number
- 10133 FDA UDI
- Primary DI / UDI-DI
- 10705037014835 EUDAMEDFDA UDI
- Basic UDI-DI
- 0705037A130000000000013ML EUDAMED
- FDA Product Code
- MLR FDA UDI
- EMDN Code
- S900101 HYDROGEN PEROXIDE CARTRIDGES EUDAMED
- GMDN Term
- Hydrogen peroxide device sterilant FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 880.6860 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
No
Over-the-Counter
Yes
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Hydrogen peroxide device sterilant
Sterrad by Advanced Sterilization Products Services Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Hydrogen peroxide device sterilant.
- Liquid Ultra — CROSSTEX INTERNATIONAL, INC. · Class I
- Sterling Medical Products — APOLLO MEDICAL PRODUCTS CORP.
- 125-280 Solution™ for STERIZONE VP4 Sterilizer — Tso3, Inc. · Class II
- VAPROX — STERIS CORPORATION · Class II
- SPOROX® II — Sultan Healthcare Inc · Class II
- VAPROX — STERIS CORPORATION · Class II
- SPOROX® — Sultan Healthcare Inc · Class II
- Compliance — METREX RESEARCH · Class II
Cleared under the same submission
K042116 also covers:
K142454 also covers:
- Sterrad — ADVANCED STERILIZATION PRODUCTS SERVICES INC.
- Sterrad — ADVANCED STERILIZATION PRODUCTS SERVICES INC.
- Sterrad — ADVANCED STERILIZATION PRODUCTS SERVICES INC.
- Sterrad — ADVANCED STERILIZATION PRODUCTS SERVICES INC.
- Sterrad — ADVANCED STERILIZATION PRODUCTS SERVICES INC.
- Sterrad — ADVANCED STERILIZATION PRODUCTS SERVICES INC.
K220404 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| 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 (2)
- FDA UDI 2ef7ae07-9b67-4f04-841f-9092e3d94e17 37 fields · synced Jun 11, 2026
- EUDAMED 15481f6e-79fc-4bb3-ba67-cec16cbe8872 61 fields · synced Jun 11, 2026