Duns Number:030650113
Device Description: Right Angle Thoracic Catheter, 20 French x 20 IN
Catalog Number
1245-20
Brand Name
Medovations®
Version/Model Number
1245-20
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
GBS
Product Code Name
Catheter, Ventricular, General & Plastic Surgery
Public Device Record Key
e128955e-3368-4872-95f9-5792af680a1d
Public Version Date
April 10, 2019
Public Version Number
3
DI Record Publish Date
September 07, 2018
Package DI Number
M7831245201
Quantity per Package
10
Contains DI Package
M7831245200
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 109 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 207 |