Catalog Number

-

Brand Name

MP-2785-G15

Version/Model Number

MP-2785-G15

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

922414e8-7a36-4fad-ba6e-ee553c24f88c

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

-