SYSTEM 1E Liquid Chemical Sterilant Processing System
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- SYSTEM 1E Liquid Chemical Sterilant Processing System FDA UDI
- Generic Name
- Liquid sterilant sterilizer FDA UDI
- Device Name
- The SYSTEM 1E Liquid Chemical Sterilant Processing System is for safe and effective reprocessing of heat-sensitive critical and semi-critical medical devices. FDA UDI
- Model / Reference
- 1E FDA UDI
- Description
- The SYSTEM 1E Liquid Chemical Sterilant Processing System is for safe and effective reprocessing of heat-sensitive critical and semi-critical medical devices. FDA UDI
Identifiers
- Catalog Number
- 6500 FDA UDI
- Primary DI / UDI-DI
- 00724995092986 FDA UDI
- 510(k) Number
- K090036 FDA UDIK101409 FDA UDIK102462 FDA UDIK113520 FDA UDIK131078 FDA UDIK161683 FDA UDIK170956 FDA UDIK180342 FDA UDIK190104 FDA UDIK192929 FDA UDIK210737 FDA UDIK211607 FDA UDIK222615 FDA UDIK232914 FDA UDI
- FDA Product Code
- MED FDA UDI
- GMDN Term
- Liquid sterilant sterilizer FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.6885 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Contains Latex
No
Prescription Use
No
Over-the-Counter
Yes
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Liquid sterilant sterilizer
SYSTEM 1E Liquid Chemical Sterilant Processing System by Corporation Steris Canada — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Liquid sterilant sterilizer.
- enspire — STERIS CORPORATION · Class II
- enspire — STERIS CORPORATION · Class II
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- Patterson® — PATTERSON DENTAL SUPPLY, INC. · Class II
- Patterson® — PATTERSON DENTAL SUPPLY, INC. · Class II
- enspire — STERIS CORPORATION · Class II
- SYSTEM 1 endo — Corporation Steris Canada · Class II
Cleared under the same submission
K090036 also covers:
K101409 also covers:
K102462 also covers:
K113520 also covers:
K131078 also covers:
K161683 also covers:
K170956 also covers:
K180342 also covers:
K190104 also covers:
K192929 also covers:
K210737 also covers:
K211607 also covers:
K222615 also covers:
K232914 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
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
- Corporation Steris Canada
Sources (1)
- FDA UDI 230c69a3-e931-41a2-bd78-f841d26fedee 36 fields · synced May 30, 2026