First Aid Only - 2"x 4yd Non-Sterile Gauze Roll 2/Box - Acme United Corporation

Duns Number:001180207

Device Description: 2"x 4yd Non-Sterile Gauze Roll 2/Box

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More Product Details

Catalog Number

B204

Brand Name

First Aid Only

Version/Model Number

B204

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

NAB

Product Code Name

Gauze / Sponge,Nonresorbable For External Use

Device Record Status

Public Device Record Key

7f026cd1-5466-4800-8596-8fa6a454e8e7

Public Version Date

July 23, 2021

Public Version Number

1

DI Record Publish Date

July 15, 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