Catalog Number

48012512

Brand Name

Dornier MedTech

Version/Model Number

APP3515S

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

EYA

Product Code Name

Stylet, Ureteral

Public Device Record Key

c20a6beb-f650-4cdd-bcd5-14d54237808c

Public Version Date

January 04, 2019

Public Version Number

1

DI Record Publish Date

December 04, 2018

Package DI Number

00810116020614

Quantity per Package

5

Contains DI Package

00810116020553

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box