Catalog Number

-

Brand Name

NC305000

Version/Model Number

NC305000

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

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

K060268,K060268

Product Code

GBM

Product Code Name

Catheter, Urethral

Public Device Record Key

b38ce8d0-bf3e-450e-964d-772f0b77a9a4

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 24, 2016

Package DI Number

10816336021049

Quantity per Package

10

Contains DI Package

10816336020417

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-