Duns Number:741021943
Device Description: Trophon EPR USA Variant AHECC 8419.20.00 (GE VARIANT)
Catalog Number
-
Brand Name
Trophon EPR
Version/Model Number
N00010-US
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K103059,K103059
Product Code
OUJ
Product Code Name
High Level Disinfection Reprocessing Instrument For Ultrasonic Transducers
Public Device Record Key
f43cd76d-2012-4b2b-9b9b-6240056e9531
Public Version Date
March 19, 2021
Public Version Number
6
DI Record Publish Date
September 21, 2016
Package DI Number
09350855000108
Quantity per Package
1
Contains DI Package
09350855000009
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 7 |