Catalog Number

7-64553

Brand Name

Gynex SpecuLume EZ

Version/Model Number

7-64553

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

HIC

Product Code Name

Speculum, Vaginal, Nonmetal, Fiberoptic

Public Device Record Key

3af0f2bb-75f6-4e49-8dfc-6e1fab2f4c4e

Public Version Date

March 03, 2020

Public Version Number

2

DI Record Publish Date

October 16, 2019

Package DI Number

10816908010815

Quantity per Package

25

Contains DI Package

00816908010818

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box