LimiTorr™ - LIMITORR 30 MLVolume Limiting External CSF - Integra Lifesciences Corporation

Duns Number:083171244

Device Description: LIMITORR 30 MLVolume Limiting External CSF Drainage System with 20ml Burette.LimiTorr Volu LIMITORR 30 MLVolume Limiting External CSF Drainage System with 20ml Burette.LimiTorr Volume Limiting External CSF Drainage and Monitoring System provides a closed system for the drainage of cerebrospinal fluid (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 CSFdrainage. The burette in the Volume Limiting External CSF Drainage System contains a volume limiting valve which stops drainage when the pre-determined volume (20ml or 30ml) is reached.

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

INS9030

Brand Name

LimiTorr™

Version/Model Number

INS9030

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

JXG

Product Code Name

Shunt, central nervous system and components

Device Record Status

Public Device Record Key

8be75c92-0a26-4471-a6fc-d2ca50076801

Public Version Date

December 15, 2020

Public Version Number

5

DI Record Publish Date

September 22, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"INTEGRA LIFESCIENCES CORPORATION" Characteristics
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