Duns Number:338664915
Device Description: This device is a sterile and single-use. This product has the proximal end flute-lipped fo This device is a sterile and single-use. This product has the proximal end flute-lipped for a easier insertion. Each catheter is provided with a radiopaque line to allow radiographic visualization. Depth markings, made with silicone points, must be found to a predefined distance as per technical specification from the beginning of the draining part that corresponds to the last punching hole in order to ease the positioning and removal of the catheter itself.
Catalog Number
20836
Brand Name
Thoracic Catheter, Straight Fr 36
Version/Model Number
20836
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
16c61acd-cda9-44f3-b1be-f97d6c027d07
Public Version Date
May 13, 2021
Public Version Number
1
DI Record Publish Date
May 05, 2021
Package DI Number
18034139292882
Quantity per Package
20
Contains DI Package
08034139292885
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 | 105 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |