Catalog Number

-

Brand Name

Wallace

Version/Model Number

ONS1633

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

d843cbe5-0e7e-406a-81a0-bae6b461ff3e

Public Version Date

October 16, 2019

Public Version Number

3

DI Record Publish Date

January 03, 2017

Package DI Number

55019315016644

Quantity per Package

100

Contains DI Package

35019315016640

Package Discontinue Date

September 27, 2019

Package Status

Not in Commercial Distribution

Package Type

Carton