ADVANCED SURGICAL LIGHT FLOOR STANDING LED - ADVANCED INSTRUMENTATIONS, INC.

Duns Number:608736880

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

-

Brand Name

ADVANCED SURGICAL LIGHT FLOOR STANDING LED

Version/Model Number

SL-500FL LED

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

April 30, 2028

Issuing Agency

In HIBCC

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

550a96ba-e9bd-4211-b211-8c6de1ed6c4e

Public Version Date

January 08, 2021

Public Version Number

2

DI Record Publish Date

May 27, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ADVANCED INSTRUMENTATIONS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 18
2 A medical device with a moderate to high risk that requires special controls. 32