Catalog Number

PFL-1070

Brand Name

METRO-PACIFICA

Version/Model Number

PFL-1070

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

c960e56e-e6ea-4c3b-adaa-2a046d7a39c6

Public Version Date

June 19, 2020

Public Version Number

2

DI Record Publish Date

April 26, 2019

Package DI Number

00609626062883

Quantity per Package

10

Contains DI Package

00609626062890

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE