Catalog Number

-

Brand Name

MP-2785-G13

Version/Model Number

MP-2785-G13

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

OIJ

Product Code Name

Biopsy Needle Guide Kit

Public Device Record Key

0f852e36-e6a9-4aab-ab6e-52f4c2c1f46d

Public Version Date

August 04, 2022

Public Version Number

3

DI Record Publish Date

July 17, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-