Dealmed - COHESIVE BANDAGE 3" x 5 yards 24/BX 6/Cs - DEALMED MEDICAL SUPPLIES LLC

Duns Number:068586441

Device Description: COHESIVE BANDAGE 3" x 5 yards 24/BX 6/Cs

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More Product Details

Catalog Number

783035

Brand Name

Dealmed

Version/Model Number

783035

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)

Yes

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

FQM

Product Code Name

Bandage, Elastic

Device Record Status

Public Device Record Key

6a8e5f6f-e093-4938-b6a5-606a6741177c

Public Version Date

September 06, 2022

Public Version Number

1

DI Record Publish Date

August 29, 2022

Additional Identifiers

Package DI Number

10817415022230

Quantity per Package

24

Contains DI Package

00817415022233

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box

"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