CODMAN HAKIM BACTISEAL - CODMAN HAKIM Precision Fixed Pressure Valve with - CODMAN & SHURTLEFF, INC.

Duns Number:607846297

Device Description: CODMAN HAKIM Precision Fixed Pressure Valve with BACTISEAL Catheters Operating Pressure: 1 CODMAN HAKIM Precision Fixed Pressure Valve with BACTISEAL Catheters Operating Pressure: 10mm H2O Very Low Range Includes: BACTISEAL Clear with Barium Stripe Ventricular Catheter 15cm, Stylet, Unitized BACTISEAL Clear with Barium Stripe Peritoneal Catheter 120cm, Right Angle Adapter, Priming Adapter and Information Manual

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More Product Details

Catalog Number

NS5466

Brand Name

CODMAN HAKIM BACTISEAL

Version/Model Number

NS5466

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 01, 2022

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

Yes

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K020667

Product Code Details

Product Code

JXG

Product Code Name

Shunt, central nervous system and components

Device Record Status

Public Device Record Key

24e77610-c21b-4fe1-b50b-c9523be4d09f

Public Version Date

October 10, 2022

Public Version Number

7

DI Record Publish Date

September 20, 2015

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CODMAN & SHURTLEFF, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 40
2 A medical device with a moderate to high risk that requires special controls. 1054
3 A medical device with high risk that requires premarket approval 11