Emergency Elastic Wrap - 4" Elastic Wrap - FIRST CARE PRODUCTS LTD

Duns Number:514694454

Device Description: 4" Elastic Wrap

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More Product Details

Catalog Number

-

Brand Name

Emergency Elastic Wrap

Version/Model Number

Emergency Elastic Wrap

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

FQM

Product Code Name

Bandage, Elastic

Device Record Status

Public Device Record Key

484a3c24-0c5b-44b8-b205-1ff35fe623f8

Public Version Date

December 08, 2021

Public Version Number

2

DI Record Publish Date

August 26, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"FIRST CARE PRODUCTS LTD" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 46