Catalog Number

-

Brand Name

FORE-SIGHT ELITE®

Version/Model Number

01-07-1100

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

Yes

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

K143675,K143675

Product Code

MUD

Product Code Name

Oximeter, Tissue Saturation

Public Device Record Key

47edf014-d418-450c-9fab-a717558e4c74

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

March 06, 2017

Package DI Number

30609538711009

Quantity per Package

10

Contains DI Package

10609538711005

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-