Catalog Number

7-34221

Brand Name

SpecuLume

Version/Model Number

7-34221

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

96791870-40a2-4795-a118-aec178d9274e

Public Version Date

March 03, 2020

Public Version Number

3

DI Record Publish Date

April 05, 2017

Package DI Number

20816908010638

Quantity per Package

4

Contains DI Package

10816908010631

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case