Catalog Number

FLC0400SACO

Brand Name

HIGHLANDER

Version/Model Number

RPL

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 28, 2017

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

-

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

ING

Product Code Name

Elevator, wheelchair, portable

Public Device Record Key

88fcb37c-8194-4cfb-91cb-113b1f225744

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

February 24, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-