Catalog Number

A4542

Brand Name

Paracervical/Pudendal Block Tray

Version/Model Number

A4542

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

OGJ

Product Code Name

Nerve Block Tray

Public Device Record Key

67d20479-98fa-492f-b8f8-4237f9d739c7

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 16, 2016

Package DI Number

20886333221084

Quantity per Package

20

Contains DI Package

00886333221080

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box