Catalog Number

UC 14115

Brand Name

UROCORE

Version/Model Number

UROCORE

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"

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

GAA

Product Code Name

Needle, Aspiration And Injection, Disposable

Public Device Record Key

ae2177a5-3f15-4ec8-9966-023c029642b2

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

December 04, 2016

Package DI Number

38033003348292

Quantity per Package

10

Contains DI Package

08033003348291

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-