Catalog Number

OVM-DL 17/35

Brand Name

OVUMPICK

Version/Model Number

OVUMPICK Double Lumen Ovum Pickup Needle 17G 35cm

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

e2f01128-a26e-4bef-b4c4-fcd7e2f907cd

Public Version Date

September 28, 2020

Public Version Number

1

DI Record Publish Date

September 18, 2020

Package DI Number

10819374021842

Quantity per Package

10

Contains DI Package

00819374021845

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-