Hermetic Lumbar Drainage Accessory Kit - LUMBAR DRAINAGE KITThe 80cm barium impregnated - Integra Lifesciences Corporation

Duns Number:083171244

Device Description: LUMBAR DRAINAGE KITThe 80cm barium impregnated silicone lumbar catheter has an open tip an LUMBAR DRAINAGE KITThe 80cm barium impregnated silicone lumbar catheter has an open tip and is cut at an angle. Approximately 18mm of the tip is multi-perforated to help improve flow and decrease the possibility of obstruction. Four tantalum impregnated length markers are placed on the proximal end of the catheter. Designed for diverting fluid from the lumbar subarachnoid space, the catheter can be inserted with a tuohy needle using percutaneous techniques. The first marker aligns with the opening in the hub of the Touhy needle, after which the markers are spaced at 5cm intervals from the first marker to allow the surgeon to gauge the length of catheter that has been implanted into the lumbar subarachnoid space. The external portion of the catheter is secured to the subcutaneous tissue in the lumbar area by the suture collar.

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More Product Details

Catalog Number

NL8508330

Brand Name

Hermetic Lumbar Drainage Accessory Kit

Version/Model Number

NL8508330

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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

K972994

Product Code Details

Product Code

JXG

Product Code Name

Shunt, central nervous system and components

Device Record Status

Public Device Record Key

076477c3-6041-4328-a479-eecb7261b7e6

Public Version Date

September 22, 2020

Public Version Number

4

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