Duns Number:002348191
Device Description: THORACIC CATHETER STRAIGHT 32 FRENCH SOFT
Catalog Number
DSTC-32S
Brand Name
PLEUR-EVAC
Version/Model Number
IPN028467
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
bda0b613-f55c-427b-b76c-aa220a5d795e
Public Version Date
January 18, 2021
Public Version Number
3
DI Record Publish Date
May 08, 2019
Package DI Number
34026704631484
Quantity per Package
10
Contains DI Package
14026704631480
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 | 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 |