Catalog Number

-

Brand Name

PrimaPro

Version/Model Number

412-45

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)

-

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

16cbc474-033a-4c5c-8ff6-b880a23bb61b

Public Version Date

December 31, 2020

Public Version Number

2

DI Record Publish Date

September 09, 2020

Package DI Number

20850022371343

Quantity per Package

10

Contains DI Package

00850022371349

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case