Duns Number:531408342
Device Description: The Cyst Puncture Catheter is a 25 cm long, radiopaque silicone elastomer catheter with a The Cyst Puncture Catheter is a 25 cm long, radiopaque silicone elastomer catheter with a tapered end terminating in a tip with a hole. The catheter features radiopaque length markings at 5, 10 and 15 cm from the tip. The catheter has 4 drainage holes, 180 degrees apart. The proximity of the holes near the tip ensures that the holes will not extend outside small cysts. Each catheter is supplied with 2 stylets: a blunt-ended stylet and a sharp-ended stylet.
Catalog Number
9ME619
Brand Name
Cyst Puncture Catheter
Version/Model Number
9ME619
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 03, 2018
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"
Yes
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
K955265
Product Code
JXG
Product Code Name
Shunt, central nervous system and components
Public Device Record Key
26144620-f251-4eda-9da3-02298d14f02f
Public Version Date
July 13, 2018
Public Version Number
4
DI Record Publish Date
October 01, 2015
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 197 |