Catalog Number

4892715-02

Brand Name

Stimuplex®

Version/Model Number

4892715-02

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

-

Product Code

BSP

Product Code Name

NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)

Public Device Record Key

2ae22e25-dded-481a-aeac-c78ae2d5663e

Public Version Date

February 11, 2022

Public Version Number

2

DI Record Publish Date

September 21, 2020

Package DI Number

04046955648986

Quantity per Package

18

Contains DI Package

04046955648979

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton