Catalog Number

US-01-025

Brand Name

NA

Version/Model Number

Uterine Sound

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

HHM

Product Code Name

Sound, Uterine

Public Device Record Key

0337cf3b-bff7-4d9c-918a-27b74dc98938

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

October 11, 2016

Package DI Number

10852073002408

Quantity per Package

25

Contains DI Package

00852073002401

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box