Duns Number:531408342
Device Description: The Integra Y- Lumbar Catheter consists of a F5 (ID: 0.8 mm) radiopaque silicone tubing wi The Integra Y- Lumbar Catheter consists of a F5 (ID: 0.8 mm) radiopaque silicone tubing with two open-ended arms (75 mm each) featuring several rows of inlet holes. The Y-shape consists of a 30 degree angle connection between the arms and the drainage catheter. The catheter overall length is 80 cm. A F5 radiopaque silicone Suture Clamp and a F8 -F5 radiopaque polypropylene Stepdown Connector (OD: 1.8 and 1.5 mm; ID: 0.8 mm) are supplied with the catheter.
Catalog Number
951103
Brand Name
Lumbar Catheter
Version/Model Number
951103
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
K944595
Product Code
JXG
Product Code Name
Shunt, central nervous system and components
Public Device Record Key
a570bade-7b78-4023-b92e-355ead68a2a7
Public Version Date
July 06, 2018
Public Version Number
3
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 |