Keystone Sterile Nasopharyngeal Non-Tapered Swab - 6 inch - Absorbent Tipped Applicator, Sterile - KEYSTONE MANUFACTURING, LLC

Duns Number:013799942

Device Description: Absorbent Tipped Applicator, Sterile

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More Product Details

Catalog Number

-

Brand Name

Keystone Sterile Nasopharyngeal Non-Tapered Swab - 6 inch

Version/Model Number

KMSWAB-600P-100

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

KXG

Product Code Name

Applicator, Absorbent Tipped, Sterile

Device Record Status

Public Device Record Key

6cdc36d0-b86e-4430-8b60-a551a91dc776

Public Version Date

August 25, 2021

Public Version Number

1

DI Record Publish Date

August 17, 2021

Additional Identifiers

Package DI Number

90860000906091

Quantity per Package

100

Contains DI Package

90860000906084

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"KEYSTONE MANUFACTURING, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 16
2 A medical device with a moderate to high risk that requires special controls. 4