Duns Number:318165065
Device Description: Genesis Urology Imaging System, Right, FPD, 65 KW, 480 V
Catalog Number
K1034267
Brand Name
Dornier MedTech
Version/Model Number
Genesis
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
K122768
Product Code
JAA
Product Code Name
System, X-Ray, Fluoroscopic, Image-Intensified
Public Device Record Key
341d8a2b-44f4-4ce9-86bb-4d14ff62a59a
Public Version Date
October 15, 2018
Public Version Number
1
DI Record Publish Date
September 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 | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 12 |
| U | Unclassified | 3 |