Identity
- Trade Name
- Sterling C2000 FDA UDI
- Generic Name
- Surgical instrument washer/disinfector (chemical/thermal) FDA UDI
- Device Name
- Steam heated 480V Standard version 1000mm (39 3/8 inch) Wide 2250mm (89 inches) Long FDA UDI
- Model / Reference
- C2000-S480 FDA UDI
- Description
- Steam heated 480V Standard version 1000mm (39 3/8 inch) Wide 2250mm (89 inches) Long FDA UDI
Identifiers
- Catalog Number
- C2000-S480 FDA UDI
- Primary DI / UDI-DI
- 10841736121594 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
Yes
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)
Sterling C2000 by Skytron, LLC — 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
- Skytron, LLC
Sources (1)
- FDA UDI 02f261a1-e2ad-40c6-b96b-d14f5b8d06cd 35 fields · synced May 31, 2026