Fischerbrand - Cotton Balls (2000ct Medium size) - U.S. COTTON, LLC

Duns Number:932938897

Device Description: Cotton Balls (2000ct Medium size)

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More Product Details

Catalog Number

-

Brand Name

Fischerbrand

Version/Model Number

B PMDL 2000 R00201 FH

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 03, 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

fbe055e5-4a94-4613-8abe-b46cbab564b4

Public Version Date

January 04, 2022

Public Version Number

3

DI Record Publish Date

February 13, 2021

Additional Identifiers

Package DI Number

10048341011832

Quantity per Package

2

Contains DI Package

00048341011835

Package Discontinue Date

September 24, 2021

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