COMEG MEDICAL TECHNOLOGIES - "This 30 Watt LED light source has been - SOPRO

Duns Number:264205501

Device Description: "This 30 Watt LED light source has been especially designed for endoscopic diagnosis appli "This 30 Watt LED light source has been especially designed for endoscopic diagnosis applications in medical practices of the following special fields: ent, gynecology, urology, veterinary. It is equipped with an electronic iris with fibre optic sensor, an automatic thermal protection system and a power level memory."

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More Product Details

Catalog Number

S_281_0002

Brand Name

COMEG MEDICAL TECHNOLOGIES

Version/Model Number

SOPRO 281 LIGHT SOURCE

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K103813

Product Code Details

Product Code

FCW

Product Code Name

Light Source, Fiberoptic, Routine

Device Record Status

Public Device Record Key

1c61a389-ea58-4237-95f7-50f01e6f1481

Public Version Date

December 22, 2021

Public Version Number

6

DI Record Publish Date

December 19, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SOPRO" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2
2 A medical device with a moderate to high risk that requires special controls. 128