Catalog Number

EV-29L-TPK-1

Brand Name

Sterile transperineal needle guide with sheath

Version/Model Number

Single Unit

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

K192303,K192303,K192303

Product Code

OIJ

Product Code Name

Biopsy Needle Guide Kit

Public Device Record Key

36389be4-ef19-447a-8390-fd01a393279e

Public Version Date

June 17, 2022

Public Version Number

2

DI Record Publish Date

February 03, 2021

Package DI Number

10628055481116

Quantity per Package

5

Contains DI Package

00628055481102

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-