NEXT-GEN - S-GEN Powder-Free Nitrile Examination Gloves, - Genesee Scientific Holdings, LLC

Duns Number:943016071

Device Description: S-GEN Powder-Free Nitrile Examination Gloves, Size XL, 200

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More Product Details

Catalog Number

44-104XL

Brand Name

NEXT-GEN

Version/Model Number

44-104XL

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

LZA

Product Code Name

Polymer Patient Examination Glove

Device Record Status

Public Device Record Key

f7692f92-d131-4dce-9066-d5e7ede54657

Public Version Date

August 26, 2022

Public Version Number

1

DI Record Publish Date

August 18, 2022

Additional Identifiers

Package DI Number

00850043811695

Quantity per Package

10

Contains DI Package

00850043811480

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-