Duns Number:196548481
Device Description: Round Silicone Wound Drain with Trocar
Catalog Number
0215-032-000
Brand Name
NA
Version/Model Number
0215032000
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 01, 2019
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
83da282a-909e-4bb2-9fbc-0432de433b35
Public Version Date
February 19, 2020
Public Version Number
2
DI Record Publish Date
September 24, 2018
Package DI Number
34546540185038
Quantity per Package
10
Contains DI Package
04546540185037
Package Discontinue Date
April 01, 2019
Package Status
Not in Commercial Distribution
Package Type
pack
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2188 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3183 |
| U | Unclassified | 60 |