Catalog Number

-

Brand Name

BASIC MEDICAL

Version/Model Number

NGPF7003C

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

4917396e-72b0-4194-8386-e2f02b70eecb

Public Version Date

November 05, 2020

Public Version Number

1

DI Record Publish Date

October 28, 2020

Package DI Number

10860002576685

Quantity per Package

10

Contains DI Package

00860002576688

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE