Duns Number:130789944
Device Description: Minnow Ureteral Catheter, 5Fr x 70cm Open Tip - Right
Catalog Number
MIOT0570R
Brand Name
Dornier MedTech
Version/Model Number
Minnow Ureteral Catheter, 5Fr x 70cm Open Tip - Right
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EYB
Product Code Name
Catheter, Ureteral, Gastro-Urology
Public Device Record Key
4f1481b0-474f-4c65-83d5-2c69a6eedfea
Public Version Date
March 04, 2020
Public Version Number
1
DI Record Publish Date
February 25, 2020
Package DI Number
00810116021543
Quantity per Package
5
Contains DI Package
00810116021505
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 28 |
2 | A medical device with a moderate to high risk that requires special controls. | 101 |