Duns Number:758568000
Device Description: Mini Incubator (MINC)
Catalog Number
K-MINC-1000
Brand Name
Cook
Version/Model Number
G20079
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
K983642
Product Code
MQG
Product Code Name
ACCESSORY, ASSISTED REPRODUCTION
Public Device Record Key
2bddff1e-b6af-47c3-851a-3e56ade1c5fe
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 24, 2016
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. | 106 |
3 | A medical device with high risk that requires premarket approval | 93 |