Catalog Number

-

Brand Name

ACE Single Lumen Ovum Pickup Needle

Version/Model Number

A-OVM-SL17/35

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"

Yes

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

K190590,K190590

Product Code

MQE

Product Code Name

Needle, Assisted Reproduction

Public Device Record Key

54fb5855-e17d-402c-81fb-6c0dcb58a5bd

Public Version Date

April 17, 2020

Public Version Number

1

DI Record Publish Date

April 09, 2020

Package DI Number

10812261016877

Quantity per Package

10

Contains DI Package

00812261016870

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-