Catalog Number

-

Brand Name

Sterling Healthcare Manufacturing

Version/Model Number

4027

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

KXF

Product Code Name

Applicator, Absorbent Tipped, Non-Sterile

Public Device Record Key

2b0e6993-4612-4e6d-aba7-3929a1974971

Public Version Date

September 29, 2022

Public Version Number

1

DI Record Publish Date

September 21, 2022

Package DI Number

10860005875518

Quantity per Package

500

Contains DI Package

00860005875511

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner Pack