Identity
- Trade Name
- STERRAD™ 100S Cassette EUDAMEDSterrad FDA UDI
- Generic Name
- Hydrogen peroxide device sterilant FDA UDI
- Device Name
- STERRAD™ 100S Cassette EUDAMEDSterrad 100s Cassette FDA UDI
- Model / Reference
- 10113 EUDAMEDFDA UDI
- Description
- Sterrad 100s Cassette FDA UDI
Identifiers
- Catalog Number
- 10113 FDA UDI
- Primary DI / UDI-DI
- 10705037014583 EUDAMEDFDA UDI
- Basic UDI-DI
- 0705037A080000000000008T3 EUDAMED
- FDA Product Code
- MLR FDA UDIFLF 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
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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: 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
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- SPOROX® II — Sultan Healthcare Inc · Class II
- VAPROX — STERIS CORPORATION · Class II
- SPOROX® — Sultan Healthcare Inc · Class II
- Compliance — METREX RESEARCH · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
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 |
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Manufacturer
- Manufacturer
- Advanced Sterilization Products Services Inc.
Sources (2)
- FDA UDI 591f3b2c-f7dc-4ef8-a122-7b4e226f7d9f 37 fields · synced Jul 21, 2026
- EUDAMED 7bfda006-726e-4f54-9779-f54d5a605cc2 61 fields · synced Jul 21, 2026