First Aid Only - Heavy Woven Adhesive Bandages, Knuckle, 50/box - Acme United Corporation

Duns Number:001180207

Device Description: Heavy Woven Adhesive Bandages, Knuckle, 50/box

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More Product Details

Catalog Number

1-850

Brand Name

First Aid Only

Version/Model Number

1-850

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

KGX

Product Code Name

Tape And Bandage, Adhesive

Device Record Status

Public Device Record Key

17cc15fa-ccc0-44c3-8859-db95527bde90

Public Version Date

August 18, 2021

Public Version Number

1

DI Record Publish Date

August 10, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"ACME UNITED CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 303