Catalog Number

E301

Brand Name

EXMOOR

Version/Model Number

E.301

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

KXF

Product Code Name

Applicator, Absorbent Tipped, Non-Sterile

Public Device Record Key

6f8e9e66-c3ab-42b4-8a86-07cc4ec87543

Public Version Date

April 08, 2019

Public Version Number

2

DI Record Publish Date

September 10, 2018

Package DI Number

05060180251925

Quantity per Package

100

Contains DI Package

05060180256159

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

A BOX