CODMAN® HOLTER® - SELKER Reservoir Standard With Nylon Base for 4mm - INTEGRA LIFESCIENCES PRODUCTION CORPORATION

Duns Number:081277700

Device Description: SELKER Reservoir Standard With Nylon Base for 4mm Burr Hole 14mm

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More Product Details

Catalog Number

82-1618

Brand Name

CODMAN® HOLTER®

Version/Model Number

821618

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"

-

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

-

Product Code Details

Product Code

JXG

Product Code Name

Shunt, central nervous system and components

Device Record Status

Public Device Record Key

c66b1f1b-db88-44f9-846f-02fbd882faa6

Public Version Date

September 30, 2022

Public Version Number

5

DI Record Publish Date

February 28, 2020

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"INTEGRA LIFESCIENCES PRODUCTION CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 15051
2 A medical device with a moderate to high risk that requires special controls. 4286
3 A medical device with high risk that requires premarket approval 2
U Unclassified 3