THE EMERGENCY ELASTIC WRAP - THE EMERGENCY ELASTIC WRAP - 4" - EINSTEIN WORKS, LLC

Duns Number:098121274

Device Description: THE EMERGENCY ELASTIC WRAP - 4"

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More Product Details

Catalog Number

-

Brand Name

THE EMERGENCY ELASTIC WRAP

Version/Model Number

1

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

7e49c9fa-0e80-4cc3-97b7-ec15c536c9d0

Public Version Date

December 08, 2021

Public Version Number

2

DI Record Publish Date

August 16, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"EINSTEIN WORKS, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 14
2 A medical device with a moderate to high risk that requires special controls. 4