Duns Number:002348191
Device Description: THORACIC TROCAR CATHETER 20 FRENCH SOFT
Catalog Number
DTRC-20S
Brand Name
PLEUR-EVAC
Version/Model Number
IPN011530
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
GBX
Product Code Name
CATHETER, IRRIGATION
Public Device Record Key
5afb4edb-a3e9-4526-a81b-0e97f91b07cf
Public Version Date
October 31, 2019
Public Version Number
2
DI Record Publish Date
September 15, 2018
Package DI Number
24026704558531
Quantity per Package
10
Contains DI Package
04026704558537
Package Discontinue Date
October 30, 2019
Package Status
Not 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 | 3195 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 13747 |
| 3 | A medical device with high risk that requires premarket approval | 3 |
| U | Unclassified | 26 |