Duns Number:401020409
Catalog Number
ROWP3500ST
Brand Name
ROCAWIRE Nitinol - 0,035 Inch Length 150cm – 3cm Straight Flexible Tip
Version/Model Number
ROWP3500ST
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"
Yes
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
-
Product Code
EYA
Product Code Name
Stylet, Ureteral
Public Device Record Key
38310223-c6fe-4cfb-8f02-4f2c322a0aa2
Public Version Date
February 07, 2019
Public Version Number
3
DI Record Publish Date
October 11, 2016
Package DI Number
03700512981961
Quantity per Package
6
Contains DI Package
03700512971962
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box label 2
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 64 |
2 | A medical device with a moderate to high risk that requires special controls. | 152 |