Catalog Number

-

Brand Name

Inteplast

Version/Model Number

NF201

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"

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

LZA

Product Code Name

Polymer Patient Examination Glove

Public Device Record Key

5dcc093c-f927-4e37-a495-61cc9dc47537

Public Version Date

June 30, 2022

Public Version Number

2

DI Record Publish Date

June 09, 2022

Package DI Number

07629350564456

Quantity per Package

100

Contains DI Package

00762935056445

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

INNER