CoFlex NL - CoFlex NL,Cohesive Flexible Elastic Latex Free - Andover Healthcare, Inc.

Duns Number:088528245

Device Description: CoFlex NL,Cohesive Flexible Elastic Latex Free Bandage Compression Self Adherent Wrap,TAN, CoFlex NL,Cohesive Flexible Elastic Latex Free Bandage Compression Self Adherent Wrap,TAN, 1"X5Yds

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More Product Details

Catalog Number

5100TN-030

Brand Name

CoFlex NL

Version/Model Number

TAN, 1"X5Yds

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)

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

9645983f-8e0f-4059-9304-5ebef6904b63

Public Version Date

April 13, 2022

Public Version Number

1

DI Record Publish Date

April 05, 2022

Additional Identifiers

Package DI Number

00724004511071

Quantity per Package

30

Contains DI Package

10724004511078

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case

"ANDOVER HEALTHCARE, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 55