FDA.reportPublic FDA data

Sim.LED 3500+ 3p

Primary DI
04250613833373
Brand
Sim.LED 3500+ 3p
Company
S.I.M.E.O.N. Medical GmbH & Co. KG
Model
141-0013150
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
KZFDevice, Medical Examination, Ac Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KZFDevice, Medical Examination, Ac PoweredGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04250613833373PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250613833373042506138333734250613833373

GMDN Terms#

Term, Definition table
TermDefinition
Fixed examination/treatment lightA fixed device intended to provide light to illuminate a site of patient examination and/or treatment. It typically consists of one or more light bulb(s) and, depending upon the design, reflectors or mirrors which focus and reflect the light. The device can be fixed to a ceiling, wall, or supported on a mobile mount. It can also be part of an operating light system consisting of 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
06945095543954zumaxZumax Medical Co., LTDKZF2026-05-21
00858480006339NOVABurton Medical, LLCKZF2026-04-02
00858480006346 NOVABurton Medical, LLCKZF2026-04-02
00858480006827 OPLEDBurton Medical, LLCKZF2026-04-02
00858480006834 AIM HIBurton Medical, LLCKZF2026-04-02
00858480006841 AIM HIBurton Medical, LLCKZF2026-04-02
00858480006858 AIM LEDBurton Medical, LLCKZF2026-04-02
00724995244286HexaLuxSTERIS CORPORATIONKZF2025-05-05
00724995244309HexaLuxSTERIS CORPORATIONKZF2025-05-05
00724995244330HexaLuxSTERIS CORPORATIONKZF2025-05-05
00724995244347HexaLuxSTERIS CORPORATIONKZF2025-05-05
00724995244378HexaLuxSTERIS CORPORATIONKZF2025-05-05
00724995244293HexaLuxSTERIS CORPORATIONKZF2025-05-05
00724995244354HexaLuxSTERIS CORPORATIONKZF2025-05-05
00724995244361HexaLuxSTERIS CORPORATIONKZF2025-05-05
00724995244385HexaLuxSTERIS CORPORATIONKZF2025-05-05
04250365155471ATMOSATMOS MedizinTechnik GmbH & Co. KGKZF2024-11-27
04250365155488ATMOSATMOS MedizinTechnik GmbH & Co. KGKZF2024-11-27
04250365155495ATMOSATMOS MedizinTechnik GmbH & Co. KGKZF2024-11-27
04250365155839ATMOSATMOS MedizinTechnik GmbH & Co. KGKZF2024-11-27
04250365155860ATMOSATMOS MedizinTechnik GmbH & Co. KGKZF2024-11-27
04250365174434ATMOSATMOS MedizinTechnik GmbH & Co. KGKZF2024-11-27
04250365174441ATMOSATMOS MedizinTechnik GmbH & Co. KGKZF2024-11-27
04250365175530ATMOSATMOS MedizinTechnik GmbH & Co. KGKZF2024-11-27
04250365189797ATMOSATMOS MedizinTechnik GmbH & Co. KGKZF2024-11-27
00724995225070NASTERIS CORPORATIONKZF2024-11-25
00724995225179NASTERIS CORPORATIONKZF2024-11-25
00724995225186NASTERIS CORPORATIONKZF2024-11-25
00724995225667NASTERIS CORPORATIONKZF2024-11-25
00724995225674NASTERIS CORPORATIONKZF2024-11-25