Catalog Number

-

Brand Name

MTG Eagle Board

Version/Model Number

100

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

EYJ

Product Code Name

Holder, Ureteral Catheter

Public Device Record Key

cccc7698-7661-48f0-a52a-0cf292fd933c

Public Version Date

July 22, 2019

Public Version Number

5

DI Record Publish Date

January 23, 2018

Package DI Number

10851593006439

Quantity per Package

1

Contains DI Package

00851593006432

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case