Catalog Number

GUTS1000LF

Brand Name

General Biopsy Tray

Version/Model Number

GUTS1000LF

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"

Yes

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

KNW

Product Code Name

Instrument, Biopsy

Public Device Record Key

d102ac98-9457-42ec-83ac-2913c50d4b99

Public Version Date

May 28, 2018

Public Version Number

1

DI Record Publish Date

April 25, 2018

Package DI Number

20886333224191

Quantity per Package

5

Contains DI Package

00886333224197

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box