Catalog Number

MTI-2500

Brand Name

OPTICS ONE

Version/Model Number

MTI-2500

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"

Yes

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

-

Product Code

NZD

Product Code Name

Stretcher, Patient Restraint

Public Device Record Key

cbf85e43-a8b2-414b-99ac-a7ad3643b124

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 24, 2016

Package DI Number

00815384023220

Quantity per Package

10

Contains DI Package

00815384023213

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

INNER PACK