Duns Number:130789944
Device Description: PTFE Coated Guide Wire 0.025", 150cm, Angle 3cm tip, flexible one end, Stiff
Catalog Number
APP2515A
Brand Name
Dornier MedTech
Version/Model Number
PTFE Coated Guide Wire, Angle, Flexible Tip, 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
ac008c3e-017f-44f3-a969-d397b0a014f6
Public Version Date
February 26, 2020
Public Version Number
1
DI Record Publish Date
February 18, 2020
Package DI Number
00810116021857
Quantity per Package
5
Contains DI Package
00810116021840
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 |