Duns Number:016898496
Device Description: NiCore Nitinol Guidewire, Guidewire with Hydrophilic Coating, Straight Tip, 0.035"(0.888mm NiCore Nitinol Guidewire, Guidewire with Hydrophilic Coating, Straight Tip, 0.035"(0.888mm) x 150cm
Catalog Number
150NFS35
Brand Name
NiCore Nitinol Guidewire
Version/Model Number
150NFS35
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
EZB
Product Code Name
STYLET FOR CATHETER, GASTRO-UROLOGY
Public Device Record Key
9d63644a-cd23-486b-9593-1d38e856cef2
Public Version Date
October 01, 2020
Public Version Number
1
DI Record Publish Date
September 23, 2020
Package DI Number
10801741051484
Quantity per Package
10
Contains DI Package
00801741051487
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CA
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 472 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1994 |
| U | Unclassified | 10 |