Duns Number:342494647
Device Description: EDITOR HFe401 0.96m US 1P IFC
Catalog Number
091230104-IFC
Brand Name
EDITOR HFe
Version/Model Number
401
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
IZO
Product Code Name
Generator, High-Voltage, X-Ray, Diagnostic
Public Device Record Key
ead0d292-8ba8-401b-b09d-89f8d748c675
Public Version Date
July 16, 2018
Public Version Number
1
DI Record Publish Date
June 13, 2018
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 |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 52 |