Catalog Number

T-1070

Brand Name

METRO-PACIFICA

Version/Model Number

T-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)

-

Device labeled as "Not made with natural rubber latex"

Yes

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

LYZ

Product Code Name

Vinyl patient examination glove

Public Device Record Key

c7bb1d13-1988-4a0f-8e7c-0392978fd538

Public Version Date

June 19, 2020

Public Version Number

2

DI Record Publish Date

June 12, 2019

Package DI Number

00609626000212

Quantity per Package

10

Contains DI Package

00609626000229

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE