Catalog Number

5312

Brand Name

PremierPro

Version/Model Number

5312

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

HIB

Product Code Name

Speculum, Vaginal, Nonmetal

Public Device Record Key

1e108ee6-ff1f-4e0d-acf3-405bec06a580

Public Version Date

July 23, 2020

Public Version Number

1

DI Record Publish Date

July 15, 2020

Package DI Number

10818566017489

Quantity per Package

4

Contains DI Package

20818566017486

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case