Hermetic™ - HERMETIC VENTRICULAR CATHETER SETThe Hermetic - Integra Lifesciences Corporation

Duns Number:083171244

Device Description: HERMETIC VENTRICULAR CATHETER SETThe Hermetic Ventricular Catheter set catheter is barium HERMETIC VENTRICULAR CATHETER SETThe Hermetic Ventricular Catheter set catheter is barium impregnated. Designed for diverting fluid from the ventricles through a series of drainage holes, the catheter can be inserted into the ventricular cavity with the stainless steel stylet. A trocar is supplied with the catheter to facilitate subcutaneous tunneling away from the burr hole. The external portion of the catheter may be secured to the scalp by the suture tab. The luer lock supplied with each ventricular catheter set will connect the catheter to any Integra external drainage system.

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More Product Details

Catalog Number

NL8508220

Brand Name

Hermetic™

Version/Model Number

NL8508220

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

K864676

Product Code Details

Product Code

JXG

Product Code Name

Shunt, central nervous system and components

Device Record Status

Public Device Record Key

f696feb2-ab15-448a-818b-5dbce588aa42

Public Version Date

October 25, 2022

Public Version Number

6

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