Catalog Number

-

Brand Name

Keystone Sterile Nasopharyngeal Flocked Swab - 6 inch

Version/Model Number

KMSWAB-600-100

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

effc7774-f424-404d-b0d8-752c8f4b0f8d

Public Version Date

August 25, 2021

Public Version Number

1

DI Record Publish Date

August 17, 2021

Package DI Number

90860000906077

Quantity per Package

100

Contains DI Package

90860000906060

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case