Duns Number:338664915
Device Description: The surgical drainage is a sterile and single-use device. Flat 3/4 profile juctionless wit The surgical drainage is a sterile and single-use device. Flat 3/4 profile juctionless with connecting tube allowing continuous and constant drainage, reducing risk of occlusion. 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
24101
Brand Name
Flat Drain 3/4 type Jackson-Pratt 3x7 mm w/trocar
Version/Model Number
24101
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
06471711-9625-45c7-aee5-001e32790f0e
Public Version Date
March 08, 2022
Public Version Number
2
DI Record Publish Date
May 05, 2021
Package DI Number
18034139294510
Quantity per Package
20
Contains DI Package
08034139294513
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 |