Duns Number:196275197
Device Description: Ultrasounds Transducer for Corometrics 116 model fetal monitor including all subsequent Co Ultrasounds Transducer for Corometrics 116 model fetal monitor including all subsequent Corometrics models.
Catalog Number
-
Brand Name
Cetro America Ultrasound Transducer for Coro 116
Version/Model Number
8031014
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
K050826
Product Code
HGM
Product Code Name
System, Monitoring, Perinatal
Public Device Record Key
e168a875-70a4-40de-9099-593ea57f8bf2
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. | 39 |