Duns Number:691795268
Device Description: This equipment is designed for providing an environment with controlled temperature, CO2, This equipment is designed for providing an environment with controlled temperature, CO2, (other gases), and elevated humidity for the development of ova or embryos at or near Body temperature.
Catalog Number
-
Brand Name
Panasonic
Version/Model Number
MCO-170MG-PA
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 31, 2019
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
fbdd3f7f-633c-40e4-8e78-5b15d7b4c002
Public Version Date
June 11, 2019
Public Version Number
4
DI Record Publish Date
October 02, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 16 |