FDA UDI
In Commercial Distribution
🇺🇸 United States
Steelco
DI: 08051520012518
·
Model: DS 1000 N1S
·
STEELCO SPA
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Steelco
- Primary DI
- 08051520012518
- Version / Model
- DS 1000 N1S
- Catalog Number
- DS 1000 N1S
- Company Name
- STEELCO SPA
- Labeler DUNS
- 428717469
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-10-16
- Public Version
- 1
- Public Version Date
- 2023-10-24
- Public Version Status
- New
- Public Device Record Key
- aa84c2de-f1c3-461e-ac0f-c04e24b9b3f6
Device 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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MEC | Disinfector, Medical Devices | General Hospital | 880.6992 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 66797 | Surgical instrument washer/disinfector (chemical/thermal) | An electrically-powered unit intended to both wash and disinfect a range of surgical instruments, and typically also ancillary utensils (e.g., containers), using both heat and a disinfectant solution; it is not dedicated to washing/disinfecting a specific device type. The device includes an internal chamber containing baskets/racks onto which the devices are placed to help maximize contact with all surfaces and parts. It is used in hospitals typically in a reprocessing suite. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 08051520012518 | GS1 |