Catalog Number

-

Brand Name

Wallace

Version/Model Number

1816ST

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

MQF

Product Code Name

CATHETER, ASSISTED REPRODUCTION

Public Device Record Key

446405b8-2f1f-477a-931e-5eac16a4087a

Public Version Date

October 16, 2019

Public Version Number

4

DI Record Publish Date

October 11, 2016

Package DI Number

55019315015678

Quantity per Package

100

Contains DI Package

35019315015674

Package Discontinue Date

September 27, 2019

Package Status

Not in Commercial Distribution

Package Type

Carton