Nautilus Surgical Light Series - LED Surgical light - SKYTRON LLC

Duns Number:078375583

Device Description: LED Surgical light

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More Product Details

Catalog Number

-

Brand Name

Nautilus Surgical Light Series

Version/Model Number

Nautilus NL

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 24, 2016

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

-

Product Code Details

Product Code

FSS

Product Code Name

Light, surgical, floor standing

Device Record Status

Public Device Record Key

0c91f706-55b7-461a-a9c5-5fb25f119bf4

Public Version Date

August 09, 2021

Public Version Number

5

DI Record Publish Date

September 19, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"SKYTRON LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 747
2 A medical device with a moderate to high risk that requires special controls. 265