CSF Reservoir - The CSF Reservoir consists of a silicone - INTEGRA NEUROSCIENCES IMPLANT (FRANCE)

Duns Number:531408342

Device Description: The CSF Reservoir consists of a silicone dome-shaped reservoir incorporating a polypropyle The CSF Reservoir consists of a silicone dome-shaped reservoir incorporating a polypropylene needle-stop, and an F8 integrated connector. The CSF Reservoir can be provided alone. Other configurations include a right angle ventricular catheter (7 cm or 9 cm length) and a 15 cm introducing rod, or a 15 cm straight ventricular catheter and a right angle guide. The ventricular catheter features radiopaque length markings at 2, 4, 6, 8, 10 cm from the tip.

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More Product Details

Catalog Number

999304

Brand Name

CSF Reservoir

Version/Model Number

999304

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

MR Conditional

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

K950315

Product Code Details

Product Code

LKG

Product Code Name

PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVENTRICULAR

Device Record Status

Public Device Record Key

baf610f9-4fa3-4329-93be-c2ba98886357

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

October 01, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"INTEGRA NEUROSCIENCES IMPLANT (FRANCE)" Characteristics
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