Identity
- Trade Name
- Steelco FDA UDI
- Generic Name
- Surgical utensil washer/disinfector FDA UDI
- Device Name
- This device is an under counter washer disinfector designed for the cleaning, thermal disinfection (intermediate level) and forced hot air drying of instruments used in surgeries, dental instruments and laboratory glassware. FDA UDI
- Model / Reference
- DS 800 2S FDA UDI
- Description
- This device is an under counter washer disinfector designed for the cleaning, thermal disinfection (intermediate level) and forced hot air drying of instruments used in surgeries, dental instruments and laboratory glassware. FDA UDI
Identifiers
- Catalog Number
- DS 800 2S FDA UDI
- Primary DI / UDI-DI
- 08058341872529 FDA UDI
- FDA Product Code
- MEC FDA UDI
- GMDN Term
- Surgical utensil washer/disinfector FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 880.6992 FDA UDI
- 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
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Surgical utensil washer/disinfector
Steelco by Steelco Spa — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Steelco Spa
Sources (1)
- FDA UDI 22ff9145-f8fe-41e6-aef7-bdafe56a9cda 34 fields · synced May 30, 2026