Duns Number:130789944
Device Description: PTFE/Nitinol Guide Wire 0.038", 150cm, Angle 3cm tip, flexible both ends, Super Stiff
Catalog Number
MERI3815AS
Brand Name
Dornier MedTech
Version/Model Number
Dual Flex with Hydrophilic Tip, Angle, Super Stiff
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
EYA
Product Code Name
Stylet, Ureteral
Public Device Record Key
1cdab456-6e15-493f-86c2-bbc5ecc30b13
Public Version Date
February 26, 2020
Public Version Number
1
DI Record Publish Date
February 18, 2020
Package DI Number
00810116022052
Quantity per Package
5
Contains DI Package
00810116022045
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 |