Catalog Number

-

Brand Name

Follicle Aspiration Set, Reduced Single Lumen

Version/Model Number

14178

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

K082727,K082727

Product Code

MQE

Product Code Name

Needle, Assisted Reproduction

Public Device Record Key

e3e2ab23-03eb-48de-ba59-8e532227ab46

Public Version Date

November 28, 2019

Public Version Number

4

DI Record Publish Date

September 23, 2016

Package DI Number

17350025914296

Quantity per Package

10

Contains DI Package

07350025914299

Package Discontinue Date

November 27, 2019

Package Status

Not in Commercial Distribution

Package Type

-