Identity
- Trade Name
- MS Sim.LED OpL wSB FDA UDI
- Generic Name
- Operating room light FDA UDI
- Device Name
- Mobile Stand - Sim.LED OR Lights with single battery FDA UDI
- Model / Reference
- 121-0016691 FDA UDI
- Description
- Mobile Stand - Sim.LED OR Lights with single battery FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04250613842405 FDA UDI
- FDA Product Code
- FSS FDA UDI
- GMDN Term
- Operating room light FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4580 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: Operating room light
MS Sim.LED OpL wSB by S.I.M.E.O.N. Medical GmbH & Co. KG — 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
- S.I.M.E.O.N. Medical GmbH & Co. KG
Sources (1)
- FDA UDI 5ee70a3d-89ff-466c-9539-6d3441f32fac 33 fields · synced Jun 8, 2026