Duns Number:002348191
Device Description: Chocolate XD Hydro Coated 140cm 3.5x10
Catalog Number
CX14-140-3510 RX
Brand Name
CHOCOLATE
Version/Model Number
IPN914598
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
LOX
Product Code Name
Catheters, transluminal coronary angioplasty, percutaneous
Public Device Record Key
6ffb8ab1-22bf-486d-9e7e-a9e6a9bdb108
Public Version Date
April 16, 2021
Public Version Number
1
DI Record Publish Date
April 08, 2021
Package DI Number
20841156105492
Quantity per Package
1
Contains DI Package
10841156105495
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 | 3195 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 13747 |
| 3 | A medical device with high risk that requires premarket approval | 3 |
| U | Unclassified | 26 |