Dealmed - Bandage Adhesive Fabric 3/4" x 3" 100/Box - DEALMED MEDICAL SUPPLIES LLC

Duns Number:068586441

Device Description: Bandage Adhesive Fabric 3/4" x 3" 100/Box

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More Product Details

Catalog Number

783810

Brand Name

Dealmed

Version/Model Number

859140003801

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

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

9c64ab33-0b25-41fc-bb3e-5cb1d93be686

Public Version Date

October 09, 2020

Public Version Number

2

DI Record Publish Date

September 14, 2020

Additional Identifiers

Package DI Number

10859140003801

Quantity per Package

24

Contains DI Package

00859140003804

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE

"DEALMED MEDICAL SUPPLIES LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 37
2 A medical device with a moderate to high risk that requires special controls. 6