Fischerbrand - Cotton Balls (1000ct Large Size) - U.S. COTTON, LLC

Duns Number:932938897

Device Description: Cotton Balls (1000ct Large Size)

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More Product Details

Catalog Number

-

Brand Name

Fischerbrand

Version/Model Number

B PLDL 1000 R00201 AC

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

378221d0-2146-48cf-a86c-b2b81f8f13f4

Public Version Date

July 07, 2020

Public Version Number

2

DI Record Publish Date

February 28, 2020

Additional Identifiers

Package DI Number

10048341011849

Quantity per Package

2

Contains DI Package

00048341011842

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