Catalog Number

-

Brand Name

Follicle Aspiration Set Single Lumen, Luer

Version/Model Number

17137

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

K161970,K161970

Product Code

MQE

Product Code Name

Needle, Assisted Reproduction

Public Device Record Key

46305919-b938-40cf-9e0f-87a199650272

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 26, 2017

Package DI Number

17350025915286

Quantity per Package

10

Contains DI Package

07350025915289

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-