Duns Number:083171244
Device Description: The LimiTorr Volume Limiting External CSF Drainage and Monitoring System provides a closed The LimiTorr Volume Limiting External CSF Drainage and Monitoring System provides a closed system for the drainage of CSF from the ventricles of the brain or the lumbar subarachnoid space to an external drainage bag. The LimiTorr Volume Limiting External CSF Drainage system was designed to include a volume limiting valve mechanism which reduces the chances for excessive CSF drainage. The burette contains a volume limiting valve which stops drainage when the pre-determine volume (20ml or 30ml) is reached.
Catalog Number
INS9020SP1
Brand Name
LimiTorr™
Version/Model Number
INS9020SP1
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
K072929
Product Code
JXG
Product Code Name
Shunt, central nervous system and components
Public Device Record Key
0a38ee41-d314-4151-887b-acc69f89ecfe
Public Version Date
December 15, 2020
Public Version Number
5
DI Record Publish Date
September 22, 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 | 14 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 75 |
| 3 | A medical device with high risk that requires premarket approval | 17 |
| U | Unclassified | 32 |