Catalog Number

-

Brand Name

Embryo transfer catheter

Version/Model Number

#4219 Emtrac Delphin

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"

-

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

K013536

Product Code

MQF

Product Code Name

Catheter, Assisted Reproduction

Public Device Record Key

76dab778-1d0d-4751-ac80-826d0073ba29

Public Version Date

February 19, 2020

Public Version Number

5

DI Record Publish Date

October 14, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-