FDA.reportPublic FDA data

Sim.LED 500 MC 9p HD

Primary DI
04250613840296
Brand
Sim.LED 500 MC 9p HD
Company
S.I.M.E.O.N. Medical GmbH & Co. KG
Model
141-0015639
Published
2018-09-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FSYLight, Surgical, Ceiling Mounted

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSYLight, Surgical, Ceiling MountedGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04250613840296PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250613840296042506138402964250613840296

GMDN Terms#

Term, Definition table
TermDefinition
Operating lightA device designed to provide a specialized source of light for illumination of a site of medical intervention. It provides a high intensity, high colour rendering field of light that minimizes shadows and the emission of heat. It typically consists of an individual light head with more than one light source which may include halogen bulbs or light-emitting diodes (LEDs), reflectors, mirrors and a mechanism to adjust the focus. This device is usually mounted to the ceiling or wall of an operating room (OR) and the mount may be included. It can be part of an OR light system comprising more than one light head.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
344838128
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04250613849282DM MS Sim.LED ExL DE121-00201962024-09-16
04250613849305MS Sim.LED OpL wSB121-00204812024-09-16
04250613849329MS Sim.LED OpL wDB121-00204822024-09-16
04250613849367MS Sim.LED OpL US121-00205022024-09-16
04250613849404DM MS Sim.LED ExL wSB121-00202072024-09-16
04250613846502Sim.LED 8000 SC 3p141-00195252024-02-15
04250613846519Sim.LED 8000 MC 3p LC Touch141-00195962024-02-05
04250613846526Sim.LED 8000 MC 5p LC Touch141-00195972024-02-05
04250613846663Sim.LED 8000 MC 3p LC141-00195942024-02-05
04250613846670Sim.LED 8000 MC 9p LC141-00195952024-02-05
04250613846786Sim.LED 8000 MC 5p LC141-00195302024-02-05
04250613846793Sim.LED 8000 MC 9p LC Touch141-00195742024-02-05
04250613846465Sim.LED 8000 MC 5p141-00195012024-01-18
04250613846533Sim.LED 8000 SC 5p141-00195822024-01-18
04250613846540Sim.LED 8000 SC 9p141-00195832024-01-18
04250613846557Sim.LED 8000 SC 3p Touch141-00195842024-01-18
04250613846564Sim.LED 8000 SC 5p Touch141-00195852024-01-18
04250613846571Sim.LED 8000 SC 5p LC141-00195862024-01-18
04250613846588Sim.LED 8000 SC 9p LC141-00195872024-01-18
04250613846595Sim.LED 8000 SC 3p LC Touch141-00195882024-01-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00684706009842iCE Surgical LightAmico Clinical Solutions CorpFSY2026-04-16
00684706009859iCE Surgical LightAmico Clinical Solutions CorpFSY2026-04-16
00684706009835iCE Surgical LightAmico Clinical Solutions CorpFSY2026-04-06
10192253051988DevonCardinal Health 200, LLCFSY2026-03-11
00684706009804iCE Surgical LightAmico Clinical Solutions CorpFSY2025-10-09
50192253021521DevonCardinal Health 200, LLCFSY2025-06-16
50192253053096DevonCardinal Health 200, LLCFSY2025-06-09
10192253052008DevonCardinal Health 200, LLCFSY2025-04-14
20192253051961DevonCardinal Health 200, LLCFSY2025-04-14
20192253051978DevonCardinal Health 200, LLCFSY2025-04-14
20192253051992DevonCardinal Health 200, LLCFSY2025-04-14
B773KLEDL0KLYOKLYO MEDICAL SYSTEMS INC.FSY2024-02-22
B773KLEDS0KLYOKLYO MEDICAL SYSTEMS INC.FSY2024-02-22
00684706007442iCE Surgical LightAmico Clinical Solutions CorpFSY2022-12-13
00684706007459iCE Surgical LightAmico Clinical Solutions CorpFSY2022-12-13
00684706007466iCE Surgical LightAmico Clinical Solutions CorpFSY2022-12-13
00684706007473iCE Surgical LightAmico Clinical Solutions CorpFSY2022-12-13
00684706007480iCE Surgical LightAmico Clinical Solutions CorpFSY2022-12-13
00684706007497iCE Surgical LightAmico Clinical Solutions CorpFSY2022-12-13
00684706007428iCE Surgical LightAmico Clinical Solutions CorpFSY2022-12-12
00684706007435iCE Surgical LightAmico Clinical Solutions CorpFSY2022-12-12
00684706007404iCE Surgical LightAmico Clinical Solutions CorpFSY2022-11-01
00684706007411iCE Surgical LightAmico Clinical Solutions CorpFSY2022-11-01
00724995199364HarmonyAIRSTERIS CORPORATIONFSY2021-04-09
00724995199388HarmonyAIRSTERIS CORPORATIONFSY2021-04-09
00724995199395HarmonyAIRSTERIS CORPORATIONFSY2021-04-09
00724995199401HarmonyAIRSTERIS CORPORATIONFSY2021-04-09
00724995199425HarmonyAIRSTERIS CORPORATIONFSY2021-04-09
00724995199432HarmonyAIRSTERIS CORPORATIONFSY2021-04-09
00724995199456HarmonyAIRSTERIS CORPORATIONFSY2021-04-09