Catalog Number

TOP 1416M

Brand Name

TOP CUT

Version/Model Number

TOP CUT M

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

K021525,K021525

Product Code

FCG

Product Code Name

Biopsy Needle

Public Device Record Key

1ad4ad76-48b0-4500-aed0-72593580514c

Public Version Date

April 08, 2022

Public Version Number

1

DI Record Publish Date

March 31, 2022

Package DI Number

48033003347384

Quantity per Package

20

Contains DI Package

08033003347386

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-