Catalog Number

-

Brand Name

Dry Incubator

Version/Model Number

EC6S-120MD

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

PUB

Product Code Name

Accessory, Assisted Reproduction, Exempt

Public Device Record Key

468941dd-38db-4b7e-af57-385b6d57ce94

Public Version Date

July 25, 2019

Public Version Number

1

DI Record Publish Date

July 17, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-