Catalog Number

-

Brand Name

i-ROOT 100

Version/Model Number

iRB-011

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

June 15, 2021

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K112508

Product Code

LQY

Product Code Name

Locator, Root Apex

Public Device Record Key

629f70b5-bdb9-45da-902f-863d58494ecd

Public Version Date

June 16, 2021

Public Version Number

2

DI Record Publish Date

March 02, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-