Catalog Number

-

Brand Name

PrimaPro

Version/Model Number

PE-3745-XL

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

FME

Product Code Name

Gown, Examination

Public Device Record Key

8b910a9d-ae6c-4615-a484-c5a5288dc9bb

Public Version Date

August 25, 2021

Public Version Number

3

DI Record Publish Date

September 18, 2020

Package DI Number

10850022371513

Quantity per Package

5

Contains DI Package

00850022371516

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case