Catalog Number

826634

Brand Name

CODMAN ICP EXPRESS

Version/Model Number

82-6634

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

September 01, 2022

Issuing Agency

In GS1

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

-

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

K945585

Product Code

GWM

Product Code Name

DEVICE, MONITORING, INTRACRANIAL PRESSURE

Public Device Record Key

97074d62-cf12-4267-8619-f919051c0f44

Public Version Date

September 01, 2022

Public Version Number

8

DI Record Publish Date

June 30, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-