Duns Number:076769355
Device Description: A PTFE coated metal wire with a flexible tip designed to position a catheter or similar in A PTFE coated metal wire with a flexible tip designed to position a catheter or similar interventional device (e.g., a stent or dilator) within an endoscope lumen into the gastrointestinal (GI) tract or the tracheobronchial tree. This is a single-use device
Catalog Number
3406
Brand Name
Flex-Ez Guidewire
Version/Model Number
3406
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
K914358
Product Code
EYB
Product Code Name
Catheter, Ureteral, Gastro-Urology
Public Device Record Key
4b631ea1-b11a-43dd-9378-aebd997b2144
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 21, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 196 |