Catalog Number

SW0103

Brand Name

Specimen Collection Swab

Version/Model Number

SW0103

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

61c4cdde-a312-47da-85ae-bcda4b35070f

Public Version Date

July 22, 2021

Public Version Number

3

DI Record Publish Date

June 24, 2020

Package DI Number

00810050852135

Quantity per Package

100

Contains DI Package

00810050852128

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case