First+Aid - Sterile Cotton Roll (0.5 oz) - U.S. COTTON, LLC

Duns Number:932938897

Device Description: Sterile Cotton Roll (0.5 oz)

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More Product Details

Catalog Number

L FZUSS 0005 R07201 FAB

Brand Name

First+Aid

Version/Model Number

L FZUSS 0005 R07201 FAB [was L FZUSS 0005 R07201 FBB]

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

May 17, 2022

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code Details

Product Code

FRL

Product Code Name

Fiber, Medical, Absorbent

Device Record Status

Public Device Record Key

5f259e87-9eb7-46e1-9103-6eb225d108f9

Public Version Date

August 16, 2022

Public Version Number

3

DI Record Publish Date

February 28, 2020

Additional Identifiers

Package DI Number

10048341007101

Quantity per Package

72

Contains DI Package

00048341007104

Package Discontinue Date

May 17, 2022

Package Status

Not in Commercial Distribution

Package Type

Case

"U.S. COTTON, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 7