Duns Number:806136177
Device Description: SABERX RADIANZ 3.5MM8CM 190
Catalog Number
R51003508L
Brand Name
SaberX Radianz
Version/Model Number
R51003508L
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"
Yes
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
K201377
Product Code
LIT
Product Code Name
Catheter, angioplasty, peripheral, transluminal
Public Device Record Key
d98aa1f0-97d2-45e5-bd03-e8ba3a20d8a3
Public Version Date
September 14, 2022
Public Version Number
2
DI Record Publish Date
March 01, 2022
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. | 2567 |
3 | A medical device with high risk that requires premarket approval | 204 |