Catalog Number

SW0101

Brand Name

Specimen Collection Swab

Version/Model Number

SW0101

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

KXG

Product Code Name

Applicator, Absorbent Tipped, Sterile

Public Device Record Key

548a53e4-32be-4a89-9737-7382f52a5d10

Public Version Date

July 22, 2021

Public Version Number

3

DI Record Publish Date

June 01, 2020

Package DI Number

00810050851879

Quantity per Package

200

Contains DI Package

00810049689988

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case