Lattice Swab - Lattice Swab for Nasopharyngeal Sample Collection. - RESOLUTION MEDICAL LLC

Duns Number:068959328

Device Description: Lattice Swab for Nasopharyngeal Sample Collection.

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More Product Details

Catalog Number

9000045

Brand Name

Lattice Swab

Version/Model Number

9000045

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)

Yes

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

5bb4ba91-3458-441a-82ee-af3527ba2352

Public Version Date

July 22, 2021

Public Version Number

2

DI Record Publish Date

August 13, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"RESOLUTION MEDICAL LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1