Duns Number:338664915
Device Description: The drainage system is composed of a silicone reservoir equipped with an anti-backflow val The drainage system is composed of a silicone reservoir equipped with an anti-backflow valve and one or two connectors, and a drainage tube. The drainage is characterized by a section equipped with drainage grooves, together with a round section portion. 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 silicone drainage is biocompatible and hemocompatible (in accordance with the regulations in force). The subject product is compatible for use with gravity or suction drainage systems. The reservoir has a capacity of 100 ml. Thanks to the typical elasticity of silicone, the drainage suction power remains constant until the reservoir is completely full. The drainage system is a sterile and single-use device.
Catalog Number
10412
Brand Name
Drentech Pump 100 ml Smart Drain w/trocar Fr 15
Version/Model Number
10412
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
GCY
Product Code Name
Apparatus, Suction, Single Patient Use, Portable, Nonpowered
Public Device Record Key
1b7a58c4-f218-497a-b6f6-e41c1a9bedbd
Public Version Date
March 08, 2022
Public Version Number
2
DI Record Publish Date
May 04, 2021
Package DI Number
18034139297122
Quantity per Package
10
Contains DI Package
08034139297125
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 |