Identity
- Trade Name
- Steelco FDA UDI
- Generic Name
- Surgical instrument washer/disinfector (chemical/thermal) 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 610/1 SL 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 610/1 SL FDA UDI
- Primary DI / UDI-DI
- 08051520018589 FDA UDI
- FDA Product Code
- MEC FDA UDI
- GMDN Term
- Surgical instrument washer/disinfector (chemical/thermal) 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 instrument washer/disinfector (chemical/thermal)
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 827801e0-e018-4b1e-90d7-c7f8f4fb31c0 34 fields · synced May 30, 2026