Catalog Number

STY23

Brand Name

Stylet for Embryo Trans 23cm/ Stylet for Twinkle Embryo Trans 23cm

Version/Model Number

Stylet 23cm (Embryo Trans/Twinkle Embryo Trans)

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

K200248,K200248

Product Code

MQF

Product Code Name

Catheter, Assisted Reproduction

Public Device Record Key

000c9a9e-b7e0-4328-b21d-843f47bdc962

Public Version Date

September 28, 2020

Public Version Number

1

DI Record Publish Date

September 18, 2020

Package DI Number

10812261016563

Quantity per Package

10

Contains DI Package

00812261016566

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-