Catalog Number

-

Brand Name

Portex

Version/Model Number

4989-18/27

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

K993619,K993619

Product Code

BSP

Product Code Name

NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)

Public Device Record Key

d071f46d-e324-462c-896a-796c919365a9

Public Version Date

November 08, 2019

Public Version Number

5

DI Record Publish Date

January 09, 2017

Package DI Number

10351688047861

Quantity per Package

10

Contains DI Package

20351688047868

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE