Catalog Number

P10603-111

Brand Name

iGUIDE®

Version/Model Number

P10603-111-223

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

-

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

K143485

Product Code

IYE

Product Code Name

Accelerator, Linear, Medical

Public Device Record Key

9cb7d39f-92a1-4c42-b3ce-bb713cc58a5f

Public Version Date

October 13, 2021

Public Version Number

2

DI Record Publish Date

August 01, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-