Duns Number:338664915
Device Description: The surgical drainage is a sterile and single-use device. The drainage has depth markings, The surgical drainage is a sterile and single-use device. The drainage has depth markings, graduated from the end of the perforated section: these markings facilitate accurate positioning of the drainage in the wound. The drainage is biocompatible and hemocompatible (in accordance with the regulations in force). The product is compatible for use with gravity or suction drainage systems.
Catalog Number
24231
Brand Name
Round Drain type Jackson-Pratt Fr 19 w/trocar
Version/Model Number
24231
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
e0201303-146f-45bc-bb42-267a2130b0c1
Public Version Date
March 08, 2022
Public Version Number
2
DI Record Publish Date
May 05, 2021
Package DI Number
18034139294718
Quantity per Package
20
Contains DI Package
08034139294711
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 |