Duns Number:809699023
Device Description: Array Multipurpose Drainage Catheter 8F x 35cm with Tight Pigtail
Catalog Number
-
Brand Name
Exodus
Version/Model Number
10521
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
K152069
Product Code
FGE
Product Code Name
CATHETER, BILIARY, DIAGNOSTIC
Public Device Record Key
bdb570cf-fb9a-45c8-a39d-cd2bf2c4bb04
Public Version Date
March 08, 2022
Public Version Number
5
DI Record Publish Date
August 05, 2016
Package DI Number
H965105211
Quantity per Package
5
Contains DI Package
H965105210
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 | 71 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1641 |