Duns Number:006261481
Device Description: STENT XD412YF RACER US SHORT
Catalog Number
-
Brand Name
RACER® BILIARY
Version/Model Number
XD412YF
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 05, 2018
Issuing Agency
In GS1
MRI safety Status
MR Conditional
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
K032768
Product Code
FGE
Product Code Name
CATHETER, BILIARY, DIAGNOSTIC
Public Device Record Key
8a25fc95-9a2f-481c-bc26-ce7948dce0ef
Public Version Date
April 08, 2022
Public Version Number
5
DI Record Publish Date
June 08, 2015
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 | 102 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 20495 |
| 3 | A medical device with high risk that requires premarket approval | 3601 |