Catalog Number

-

Brand Name

Wallace

Version/Model Number

ONS1833

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 27, 2019

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

MQE

Product Code Name

NEEDLE, ASSISTED REPRODUCTION

Public Device Record Key

8e6fe613-0b38-4cc0-b316-16af8f05f658

Public Version Date

October 16, 2019

Public Version Number

3

DI Record Publish Date

October 05, 2016

Package DI Number

35019315016848

Quantity per Package

10

Contains DI Package

15019315016844

Package Discontinue Date

September 27, 2019

Package Status

Not in Commercial Distribution

Package Type

Box