Adenna - Adenna® Bronze Disposable Latex Exam Gloves, - ADENNA LLC

Duns Number:112042723

Device Description: Adenna® Bronze Disposable Latex Exam Gloves, Powder Free, Natural, 5 mil, Ex-Large, 90/bx,

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More Product Details

Catalog Number

BRZ648

Brand Name

Adenna

Version/Model Number

BRZ648

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)

Yes

Device labeled as "Not made with natural rubber latex"

-

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

LYY

Product Code Name

Latex Patient Examination Glove

Device Record Status

Public Device Record Key

5231510f-7c89-4cea-bc09-9accf332a5ab

Public Version Date

June 19, 2020

Public Version Number

2

DI Record Publish Date

April 16, 2020

Additional Identifiers

Package DI Number

10653195276483

Quantity per Package

10

Contains DI Package

00653195276486

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box