Duns Number:826110710
Device Description: 103-0602-300 XCELERATOR14 GWIRE
Catalog Number
-
Brand Name
X-celeratorTM
Version/Model Number
103-0602-300
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
K124007
Product Code
DQX
Product Code Name
WIRE, GUIDE, CATHETER
Public Device Record Key
b0f43d05-2905-4c15-8c30-5274dd24b81e
Public Version Date
December 22, 2021
Public Version Number
4
DI Record Publish Date
July 16, 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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 1759 |
3 | A medical device with high risk that requires premarket approval | 562 |