FDA.reportPublic FDA data

Sim.CAM HD WIRELESS 10x complete

Primary DI
04250613846427
Brand
Sim.CAM HD WIRELESS 10x complete
Company
S.I.M.E.O.N. Medical GmbH & Co. KG
Model
141-0019063 SET
Device description
SET Sim.CAM HD WIRELESS 10-times camera, reuseable handle, receiver,remote control, receiver mounting SET and cables
Published
2023-06-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
KQMCamera, Surgical And Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KQMCamera, Surgical And AccessoriesGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04250613846427PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250613846427042506138464274250613846427

GMDN Terms#

Term, Definition table
TermDefinition
Surgical video cameraAn electro-optical device (e.g., a CCD) designed to obtain moving-picture documentation of an open surgical procedure. The device is designed for transducing visual images as a sequence of electronic data following a pre-established standard; the images are usually displayed sequentially on the screen of a monitor as a video image. The device may include audio recording capabilities.

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

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Primary DI, Brand, Company table
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05415334056442BarcoBarco NVKQM2026-06-02
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03700712438524Maquet OrchideMAQUET SASKQM2026-05-11
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00860014850509HMDmd Wearable Surgical MonitorHMDMD INC.KQM2025-11-22
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00848657077088AED ENDOPRO® PRIMO SERIES CAMERANATIONAL ADVANCED ENDOSCOPY DEVICES, INC.KQM2025-01-09