Catalog Number

A-OVM-SL 16/35 - M

Brand Name

ACE-M

Version/Model Number

ACE-M Manual Single Lumen Ovum Pickup Needle 16G, 35 cm

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

K190590,K190590

Product Code

MQE

Product Code Name

Needle, Assisted Reproduction

Public Device Record Key

c1f2dd21-37e9-4d11-9c98-69dc76b77034

Public Version Date

September 28, 2020

Public Version Number

1

DI Record Publish Date

September 18, 2020

Package DI Number

10819374022474

Quantity per Package

10

Contains DI Package

00819374022477

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-