Catalog Number

13366

Brand Name

Labotect

Version/Model Number

Embryo Transfer Catheter 19 cm

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K000950,K000950

Product Code

MQF

Product Code Name

Catheter, Assisted Reproduction

Public Device Record Key

6b6a01e6-edba-4c6e-9fd1-66f99a1e0ca6

Public Version Date

October 21, 2019

Public Version Number

1

DI Record Publish Date

October 11, 2019

Package DI Number

04046668001412

Quantity per Package

20

Contains DI Package

04046668002242

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

cardboard box