Catalog Number

A4382ASP

Brand Name

Standard Soft Tissue Biopsy Tray

Version/Model Number

A4382ASP

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

OJT

Product Code Name

Aspiration Tray

Public Device Record Key

d4d73967-304f-4d4b-a331-45b971080e30

Public Version Date

July 27, 2022

Public Version Number

1

DI Record Publish Date

July 19, 2022

Package DI Number

20886333220759

Quantity per Package

10

Contains DI Package

00886333220755

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box