Identity
- Trade Name
- S40 FDA UDI
- Generic Name
- Organic peroxy acid device sterilant, single-use FDA UDI
- Device Name
- The S40 Sterilant Concentrate is a single use peracetic acid-based chemistry used in the SYSTEM 1E and SYSTEM 1 endo Liquid Chemical Sterilant Processing Systems. FDA UDI
- Model / Reference
- S4000 FDA UDI
- Description
- The S40 Sterilant Concentrate is a single use peracetic acid-based chemistry used in the SYSTEM 1E and SYSTEM 1 endo Liquid Chemical Sterilant Processing Systems. FDA UDI
Identifiers
- Catalog Number
- S4000 FDA UDI
- Primary DI / UDI-DI
- 00724995090722 FDA UDI
- 510(k) Number
- K090036 FDA UDIK101409 FDA UDIK102462 FDA UDIK113520 FDA UDIK131078 FDA UDIK161683 FDA UDIK170956 FDA UDIK173256 FDA UDIK180342 FDA UDIK182827 FDA UDIK190104 FDA UDIK191343 FDA UDIK192929 FDA UDIK210737 FDA UDIK211607 FDA UDIK222615 FDA UDIK230582 FDA UDIK230930 FDA UDIK232914 FDA UDIK243433 FDA UDI
- FDA Product Code
- MED FDA UDIFEB FDA UDI
- GMDN Term
- Organic peroxy acid device sterilant, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.6885 FDA UDI876.1500 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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Organic peroxy acid device sterilant, single-use
S40 by Steris Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K230582 also covers:
K230930 also covers:
K243433 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 | Class II | Pending data |
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Manufacturer
- Manufacturer
- Steris Corporation
Sources (1)
- FDA UDI 64409ede-55eb-4a3a-b456-9c929fd3b8cd 37 fields · synced Jun 8, 2026