Catalog Number

E301CM

Brand Name

EXMOOR

Version/Model Number

E.301CM

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

a40a0508-4b8d-49cb-96e8-4899a91edebd

Public Version Date

October 15, 2019

Public Version Number

2

DI Record Publish Date

November 27, 2018

Package DI Number

05060180253158

Quantity per Package

100

Contains DI Package

05060180258740

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

a box