Duns Number:187502109
Device Description: [Ureteral Kit: 2 - Ureteral Catheters, 6 Fr Outer Diameter, 70 cm Length, 2 - Emitting Fi [Ureteral Kit: 2 - Ureteral Catheters, 6 Fr Outer Diameter, 70 cm Length, 2 - Emitting Fiber, 0.75 Outer Diameter, 370 cm Length, Do not use if package is damaged]
Catalog Number
0220180518
Brand Name
IRIS
Version/Model Number
0220180518
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
Yes
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
K151243,K151243
Product Code
FCS
Product Code Name
Light, catheter, fiberoptic, glass, ureteral
Public Device Record Key
6444a0fd-a4dd-43dc-bb3c-25679bb7c6d2
Public Version Date
February 07, 2019
Public Version Number
4
DI Record Publish Date
September 23, 2016
Package DI Number
37613327174817
Quantity per Package
5
Contains DI Package
07613327174816
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
pack
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2188 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3183 |
| U | Unclassified | 60 |