Catalog Number

HS NOTA18200

Brand Name

HS NOTA

Version/Model Number

HS NOTA

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

K131925

Product Code

FCG

Product Code Name

Biopsy Needle

Public Device Record Key

6fa38be3-9766-43e3-9d91-65d589690f83

Public Version Date

November 19, 2020

Public Version Number

1

DI Record Publish Date

November 11, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-