Catalog Number

-

Brand Name

Wallace

Version/Model Number

PEB623

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

a19abf35-d4a4-4c22-a36e-1cb70db127fd

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

December 07, 2016

Package DI Number

55019315056695

Quantity per Package

100

Contains DI Package

35019315056691

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CARTON