MS Sim.LED ExL US - Mobile Stand - examination lights USA - S.I.M.E.O.N. Medical GmbH & Co. KG

Duns Number:344838128

Device Description: Mobile Stand - examination lights USA

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More Product Details

Catalog Number

-

Brand Name

MS Sim.LED ExL US

Version/Model Number

121-0015832

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

FSS

Product Code Name

Light, Surgical, Floor Standing

Device Record Status

Public Device Record Key

eafbb194-fbbb-457b-b424-9fac06b34c93

Public Version Date

February 04, 2022

Public Version Number

1

DI Record Publish Date

January 27, 2022

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