Catalog Number

-

Brand Name

Follicle Aspiration Set, Double Lumen

Version/Model Number

14158

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

November 27, 2019

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

K991273,K991273

Product Code

MQE

Product Code Name

Needle, Assisted Reproduction

Public Device Record Key

8371eac3-e22b-409c-b6bd-59046cb20b59

Public Version Date

November 28, 2019

Public Version Number

4

DI Record Publish Date

September 09, 2016

Package DI Number

17350025911578

Quantity per Package

10

Contains DI Package

07350025911571

Package Discontinue Date

November 27, 2019

Package Status

Not in Commercial Distribution

Package Type

-