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Polaris 100/200
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref G16980Model 103024XK19X000
Identity
- Trade Name
- Polaris 100/200 EUDAMEDFDA UDI
- Generic Name
- Operating room light FDA UDI
- Model / Reference
- G16980 EUDAMEDFDA UDI103024XK19X000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04048675268109 EUDAMEDFDA UDI
- Basic UDI-DI
- 040486751103024XK19X0006L EUDAMED
- Direct Marketing DI
- 04048675268109 EUDAMED
- 510(k) Number
- K123776 FDA UDI
- FDA Product Code
- FTD FDA UDI
- EMDN Code
- Z12010701,Z12010702 EUDAMED
- GMDN Term
- Operating room light FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4580 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Operating room light
Polaris 100/200 by Drägerwerk AG & Co. KGaA — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Operating room light.
- iCE Surgical Light — Amico Clinical Solutions Corp · Class II
- iCE Surgical Light — Amico Clinical Solutions Corp · Class II
- Medical Boom — Amico Clinical Solutions Corp · Class II
- HarmonyAIR — STERIS CORPORATION · Class II
- HarmonyAIR — STERIS CORPORATION · Class II
- Medical Boom — Amico Clinical Solutions Corp · Class II
- iCE Surgical Light — Amico Clinical Solutions Corp · Class II
- HarmonyAIR — STERIS CORPORATION · Class II
Cleared under the same submission
K123776 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Drägerwerk AG & Co. KGaA
Sources (2)
- FDA UDI 31923cb2-bb22-4c9a-a22f-b5fa2dce5af7 34 fields · synced Jul 9, 2026
- EUDAMED 223159b6-2bb3-4760-ad19-839215a1cb31 61 fields · synced Jul 9, 2026