Catalog Number

43-101XL

Brand Name

NEXT-GEN

Version/Model Number

43-101XL

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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

LYY

Product Code Name

Latex Patient Examination Glove

Public Device Record Key

9053bfc1-50c0-42f9-92e6-cb0fc6f52921

Public Version Date

August 26, 2022

Public Version Number

1

DI Record Publish Date

August 18, 2022

Package DI Number

00850043811541

Quantity per Package

10

Contains DI Package

00850043811336

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-