Catalog Number

MCXS1620BX

Brand Name

Co-Axial Introducer Needle

Version/Model Number

MCXS1620BX

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

KNW

Product Code Name

Instrument, Biopsy

Public Device Record Key

28d12cc6-4709-489e-8d0b-f61e38c1b250

Public Version Date

July 29, 2022

Public Version Number

1

DI Record Publish Date

July 21, 2022

Package DI Number

20886333226324

Quantity per Package

10

Contains DI Package

00886333226320

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box