Catalog Number

13372

Brand Name

Labotect

Version/Model Number

Insemination Catheter

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

afaf574f-6606-4ac3-b886-e82845c7bbd2

Public Version Date

October 24, 2019

Public Version Number

1

DI Record Publish Date

October 16, 2019

Package DI Number

04046668001429

Quantity per Package

20

Contains DI Package

04046668002815

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

cardboard box