Duns Number:342800789
Device Description: Complete System Uroview FD Left Configuration
Catalog Number
-
Brand Name
N/A
Version/Model Number
01169034-S
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
K161019,K161019
Product Code
JAA
Product Code Name
System, X-Ray, Fluoroscopic, Image-Intensified
Public Device Record Key
18e06d46-6fe4-4dd0-b5c4-d7d9b1e41d79
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
June 08, 2017
Package DI Number
04260491620057
Quantity per Package
1
Contains DI Package
04260491620040
Package Discontinue Date
-
Package Status
In Commercial Distribution
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. | 6 |