Duns Number:946734808
Device Description: LUTONIX® 035 Drug Coated Balloon PTA Catheter .035" 130cm 5x150mm
Catalog Number
BSCLX351305150
Brand Name
LUTONIX® Drug Coated Balloon
Version/Model Number
BSCLX351305150
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
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
OUR
Product Code Name
Sacroiliac joint fixation
Public Device Record Key
8902f979-356b-4989-a0a6-f8650818851c
Public Version Date
September 04, 2019
Public Version Number
4
DI Record Publish Date
July 06, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |
| 3 | A medical device with high risk that requires premarket approval | 391 |