Identity
- Trade Name
- GOLD SMART WS FDA UDI
- Generic Name
- Radiology picture archiving and communication system workstation FDA UDI
- Device Name
- The GOLD™ SMART Workstation is an image management system whose intended use is to retrieve, archive, and distribute medical images and data from and to all vendor modalities and hospital information systems. FDA UDI
- Model / Reference
- v1.7 FDA UDI
- Description
- The GOLD™ SMART Workstation is an image management system whose intended use is to retrieve, archive, and distribute medical images and data from and to all vendor modalities and hospital information systems. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00859873006028 FDA UDI
- FDA Product Code
- LMB FDA UDI
- GMDN Term
- Radiology picture archiving and communication system workstation FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 892.2010 FDA UDI
- Commercial Distribution
- Not 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Gold Smart Ws by Hermes Medical Solutions AB — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 I | Pending data |
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Manufacturer
- Manufacturer
- Hermes Medical Solutions AB
Sources (1)
- FDA UDI 7c5797fb-526e-4c6f-8794-8eb405ba9aa8 35 fields · synced Jun 8, 2026