Catalog Number

783106

Brand Name

Dealmed

Version/Model Number

817415020758

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

FQM

Product Code Name

BANDAGE, ELASTIC

Public Device Record Key

72ea7402-11aa-4805-82af-0770a828e2db

Public Version Date

January 31, 2022

Public Version Number

4

DI Record Publish Date

September 11, 2020

Package DI Number

00817415020758

Quantity per Package

8

Contains DI Package

00817415020581

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE