Catalog Number

-

Brand Name

Wallace

Version/Model Number

PE623

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"

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

bd8b5952-db43-4dcd-8121-b5ab50bcd98b

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

December 07, 2016

Package DI Number

35019315056677

Quantity per Package

10

Contains DI Package

15019315056673

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX