Sim.LED 5000 SC 3p - S.I.M.E.O.N. Medical GmbH & Co. KG

Duns Number:344838128

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More Product Details

Catalog Number

-

Brand Name

Sim.LED 5000 SC 3p

Version/Model Number

141-0014740

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

FSY

Product Code Name

Light, Surgical, Ceiling Mounted

Device Record Status

Public Device Record Key

861fdd68-bf25-4aef-a688-7fd7c08e6ff4

Public Version Date

January 08, 2021

Public Version Number

3

DI Record Publish Date

September 24, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"S.I.M.E.O.N. MEDICAL GMBH & CO. KG" 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. 106