Duns Number:690543319
Device Description: RADIFOCUS GLIDECATH
Catalog Number
RF*YE15110A
Brand Name
GLIDECATH
Version/Model Number
CG514
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
DQO
Product Code Name
CATHETER, INTRAVASCULAR, DIAGNOSTIC
Public Device Record Key
8c1bf35e-3986-4312-8f51-11f2727770c9
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 09, 2016
Package DI Number
54987350772591
Quantity per Package
5
Contains DI Package
34987350772597
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 11 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 364 |
| 3 | A medical device with high risk that requires premarket approval | 29 |