Catalog Number

NXL200G

Brand Name

AMBITEX

Version/Model Number

NXL200G

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)

-

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

LZA

Product Code Name

Polymer patient examination glove

Public Device Record Key

b2daaade-9a06-438a-9d36-f188ddd3de64

Public Version Date

September 10, 2021

Public Version Number

1

DI Record Publish Date

September 02, 2021

Package DI Number

10699320000233

Quantity per Package

10

Contains DI Package

00699320000236

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE