Catalog Number

ROWP3500ST

Brand Name

ROCAWIRE Nitinol - 0,035 Inch Length 150cm – 3cm Straight Flexible Tip

Version/Model Number

ROWP3500ST

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"

Yes

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

38310223-c6fe-4cfb-8f02-4f2c322a0aa2

Public Version Date

February 07, 2019

Public Version Number

3

DI Record Publish Date

October 11, 2016

Package DI Number

03700512981961

Quantity per Package

6

Contains DI Package

03700512971962

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box label 2