Catalog Number

DE-016

Brand Name

InnoFine

Version/Model Number

DE-016

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

-

Product Code

OIJ

Product Code Name

Biopsy Needle Guide Kit

Public Device Record Key

9bb07f03-9b86-4b22-9687-dd780b30a45c

Public Version Date

June 17, 2022

Public Version Number

3

DI Record Publish Date

April 27, 2020

Package DI Number

16971554725163

Quantity per Package

20

Contains DI Package

06971554725166

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-