Duns Number:001188390
Device Description: Flexi-Holder GE W/Artic 26" Arm, Huestis Part# FH410-GE
Catalog Number
-
Brand Name
Husetis Medical Flexi-Holder
Version/Model Number
FH410-GE
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 05, 2016
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
K792721
Product Code
IXA
Product Code Name
Cassette, Radiographic Film
Public Device Record Key
c2297f0c-3433-41c6-a98f-dd56d1dce852
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
November 01, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 7 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 21 |