Catalog Number

TIO60-100

Brand Name

TIO™

Version/Model Number

10884450122775

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

MNK

Product Code Name

Endoscopic bite block

Public Device Record Key

005ebfa3-2944-4004-b7e8-7832ac605fd8

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

February 16, 2018

Package DI Number

20884450122772

Quantity per Package

4

Contains DI Package

10884450122775

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-