Catalog Number

-

Brand Name

Nunc IVF ICSI Dish

Version/Model Number

150265

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

-

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

K090429,K090429,K090429

Product Code

MQK

Product Code Name

LABWARE, ASSISTED REPRODUCTION

Public Device Record Key

fd80aed5-4d15-47b0-9b5f-6d4b785ff367

Public Version Date

March 10, 2021

Public Version Number

3

DI Record Publish Date

September 09, 2018

Package DI Number

00866630000427

Quantity per Package

120

Contains DI Package

00866630000410

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case