Amazon Basics - Amazon Basics Heavy Duty Fabric Adhesive - AMAZON.COM SERVICES LLC

Duns Number:128990418

Device Description: Amazon Basics Heavy Duty Fabric Adhesive Bandages, One Size, 100 Count

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More Product Details

Catalog Number

B09KCLLJ4G

Brand Name

Amazon Basics

Version/Model Number

B09KCLLJ4G

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

March 28, 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"

Yes

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

df11341e-32ca-44f8-9dce-387d117b3e90

Public Version Date

March 29, 2022

Public Version Number

2

DI Record Publish Date

October 27, 2021

Additional Identifiers

Package DI Number

10195515026939

Quantity per Package

12

Contains DI Package

00195515026932

Package Discontinue Date

March 28, 2022

Package Status

Not in Commercial Distribution

Package Type

Case

"AMAZON.COM SERVICES LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 1
2 A medical device with a moderate to high risk that requires special controls. 8