Duns Number:094651270
Device Description: DRAINAGE CATHETER - 12 FRENCH, A Silicone Chest Drainage Catheter with Trocar
Catalog Number
4141209
Brand Name
THORA-CATH
Version/Model Number
12 French
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"
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
K941232,K941232
Product Code
JOL
Product Code Name
Catheter And Tip, Suction
Public Device Record Key
a7bc6b1d-0cc4-4ea2-a28d-7cc1d5219a5c
Public Version Date
June 19, 2020
Public Version Number
5
DI Record Publish Date
September 23, 2016
Package DI Number
H67141412091
Quantity per Package
10
Contains DI Package
H67141412090
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 | 35 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 274 |