Catalog Number

515-511

Brand Name

ROTH URETHRAL SUTURE GUIDE

Version/Model Number

515-511

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

-

Product Code

GDM

Product Code Name

NEEDLE, ASPIRATION AND INJECTION, REUSABLE

Public Device Record Key

3bf851ec-949f-49a3-ac3f-f4cc50c7baf7

Public Version Date

March 21, 2019

Public Version Number

2

DI Record Publish Date

September 20, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-