Catalog Number

-

Brand Name

CT37 Incubator

Version/Model Number

GDCT37-M-4

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

fd930614-27cb-4972-926c-7a21b9e9f0f6

Public Version Date

October 28, 2019

Public Version Number

2

DI Record Publish Date

April 03, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-