Catalog Number

-

Brand Name

Culture Dish 40 mm

Version/Model Number

16001

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

K123641,K123641

Product Code

MQK

Product Code Name

Labware, Assisted Reproduction

Public Device Record Key

642061e5-0fe3-4aef-846d-692803190f20

Public Version Date

March 10, 2021

Public Version Number

5

DI Record Publish Date

June 15, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-