Catalog Number

-

Brand Name

Custom Medical Specialties, Inc.

Version/Model Number

CMS-8114

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

KXG

Product Code Name

Applicator, Absorbent Tipped, Sterile

Public Device Record Key

19476255-694f-4f7c-b9a1-6afa4295d7a5

Public Version Date

January 08, 2021

Public Version Number

4

DI Record Publish Date

December 08, 2016

Package DI Number

00815849022126

Quantity per Package

75

Contains DI Package

00815849022119

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-