Catalog Number

-

Brand Name

Full Biopsy Set

Version/Model Number

79-0012

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

OJV

Product Code Name

Single Use Instrument Tray

Public Device Record Key

b7cace43-0d0a-4f44-86a7-c0d2fabb0fbe

Public Version Date

July 08, 2022

Public Version Number

1

DI Record Publish Date

June 30, 2022

Package DI Number

05060745555512

Quantity per Package

12

Contains DI Package

05060745555505

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-