Catalog Number

TPEB-ETC-SB

Brand Name

Twinkle Pro with Soft Obturator

Version/Model Number

TWINKLE PRO EMBRYO TRANS Embryo Transfer Catheter with Soft Obturator

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

d9fed2cc-4356-45dc-a6c5-0b96d112e3ad

Public Version Date

September 28, 2020

Public Version Number

1

DI Record Publish Date

September 18, 2020

Package DI Number

10819374021859

Quantity per Package

10

Contains DI Package

00819374021852

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-