Catalog Number

EV-BIOGR

Brand Name

Reusable Needle Guide for use with the Exact Imaging EV29L Transducer

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

-

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

K180636

Product Code

OIJ

Product Code Name

Biopsy Needle Guide Kit

Public Device Record Key

0fb14a12-76bf-4f55-b606-f02a0e3ef486

Public Version Date

June 17, 2022

Public Version Number

5

DI Record Publish Date

June 01, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-