Catalog Number

9401

Brand Name

ARROW

Version/Model Number

IPN033774

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

-

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

K072045,K072045,K072045

Product Code

FCG

Product Code Name

Biopsy needle

Public Device Record Key

218ce561-a19c-4e91-99be-ca7eed1d2292

Public Version Date

January 18, 2021

Public Version Number

8

DI Record Publish Date

September 16, 2016

Package DI Number

40816000012473

Quantity per Package

20

Contains DI Package

10816000012472

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton