Catalog Number

-

Brand Name

BNX

Version/Model Number

N-22-05

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

K103668,K103668

Product Code

FCG

Product Code Name

Biopsy needle

Public Device Record Key

ffcb5bc5-2b7b-4c0c-860c-6fb85c21645c

Public Version Date

May 12, 2021

Public Version Number

4

DI Record Publish Date

September 24, 2016

Package DI Number

10855208005060

Quantity per Package

5

Contains DI Package

00855208005063

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

PACK_OR_INNER_PACK