FDA.reportPublic FDA data

Sim.LED 5000 SC 5p

Primary DI
04250613843341
Brand
Sim.LED 5000 SC 5p
Company
S.I.M.E.O.N. Medical GmbH & Co. KG
Model
141-0017227
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
04250613843341PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250613843341042506138433414250613843341

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
04251339907300YLED-3F (including Portegra)MAVIG GmbHFSY2026-07-21
04251339907317YLED-3F (including Portegra)MAVIG GmbHFSY2026-07-21
04251339907324YLED-2F (including Portegra)MAVIG GmbHFSY2026-07-21
04251339907348YLED-2F (including Portegra)MAVIG GmbHFSY2026-07-21
04251339907362YLED-2F (including Portegra)MAVIG GmbHFSY2026-07-21
04251339907379YLED-3F (including Portegra)MAVIG GmbHFSY2026-07-21
03700712436124VolistaMAQUET SASFSY2026-07-20
03700712436131VolistaMAQUET SASFSY2026-07-20
03700712436148VolistaMAQUET SASFSY2026-07-20
03700712436155VolistaMAQUET SASFSY2026-07-20
03700712436162VolistaMAQUET SASFSY2026-07-20
03700712436179VolistaMAQUET SASFSY2026-07-20
03700712436186VolistaMAQUET SASFSY2026-07-20
03700712436193VolistaMAQUET SASFSY2026-07-20
03700712436209VolistaMAQUET SASFSY2026-07-20
03700712436216VolistaMAQUET SASFSY2026-07-20
03700712436223VolistaMAQUET SASFSY2026-07-20
03700712436230VolistaMAQUET SASFSY2026-07-20
03700712436247VolistaMAQUET SASFSY2026-07-20
03700712436254VolistaMAQUET SASFSY2026-07-20
03700712436261VolistaMAQUET SASFSY2026-07-20
03700712436278VolistaMAQUET SASFSY2026-07-20
03700712436285VolistaMAQUET SASFSY2026-07-20
03700712436292VolistaMAQUET SASFSY2026-07-20
03700712436308VolistaMAQUET SASFSY2026-07-20
03700712436315VolistaMAQUET SASFSY2026-07-20
03700712436322VolistaMAQUET SASFSY2026-07-20
03700712436339VolistaMAQUET SASFSY2026-07-20
03700712436346VolistaMAQUET SASFSY2026-07-20
03700712436353VolistaMAQUET SASFSY2026-07-20