Endurance - High Risk Nitrile Powder Free Medical Exam - ECON DISPOSABLE SUPPLIES, INC

Duns Number:018198668

Device Description: High Risk Nitrile Powder Free Medical Exam Gloves, 50/BX, Long Cuff, L

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More Product Details

Catalog Number

-

Brand Name

Endurance

Version/Model Number

EDC903-BX

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

LZA

Product Code Name

Polymer Patient Examination Glove

Device Record Status

Public Device Record Key

9021cacb-2d3b-4297-ae72-70c0e4b6e9ea

Public Version Date

October 10, 2022

Public Version Number

1

DI Record Publish Date

October 01, 2022

Additional Identifiers

Package DI Number

20857420007317

Quantity per Package

10

Contains DI Package

10857420007310

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case

"ECON DISPOSABLE SUPPLIES, INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 87