Catalog Number

100-0019

Brand Name

Foam Swab 20 Pack

Version/Model Number

100-0019

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

August 04, 2016

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

P150024

Product Code

OYF

Product Code Name

Aspiration Therapy System

Public Device Record Key

0cd96962-4148-4941-bbef-1117212e4c54

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

July 25, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-