FDA.report

Sim.LED 7000 MC 5p

Primary DI
04250613843310
Brand
Sim.LED 7000 MC 5p
Company
S.I.M.E.O.N. Medical GmbH & Co. KG
Model
141-0017224
Published
2018-09-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
FSYLight, Surgical, Ceiling Mounted

Product Code Classifications

CodeDeviceSpecialtyClass
FSYLight, Surgical, Ceiling MountedGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04250613843310PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04250613843310042506138433104250613843310

GMDN Terms

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

Regulatory Flags

DUNS number
344838128
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

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

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