Catalog Number

-

Brand Name

FORE-SIGHT®

Version/Model Number

01-07-1002

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)

Yes

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

K112820,K112820

Product Code

MUD

Product Code Name

Oximeter, Tissue Saturation

Public Device Record Key

b0bdf09d-b1f2-486d-825c-a5b133f28ae3

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

March 06, 2017

Package DI Number

30609538710026

Quantity per Package

10

Contains DI Package

10609538710022

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-