First+Aid - Cotton Balls (300ct Large Size) - U.S. COTTON, LLC

Duns Number:932938897

Device Description: Cotton Balls (300ct Large Size)

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More Product Details

Catalog Number

B GRDL 0300 R03606 FAB

Brand Name

First+Aid

Version/Model Number

B GRDL 0300 R03606 FAB [was B GRDL 0300 R03606 FBB]

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)

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

3dcd82b0-2b28-4124-9270-59f16c409b0c

Public Version Date

February 04, 2021

Public Version Number

3

DI Record Publish Date

February 28, 2020

Additional Identifiers

Package DI Number

10048341007019

Quantity per Package

36

Contains DI Package

00048341007012

Package Discontinue Date

-

Package Status

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