Catalog Number

0295003000

Brand Name

NA

Version/Model Number

0295003000

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

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

LXC

Product Code Name

MONITOR, PRESSURE, INTRACOMPARTMENTAL

Public Device Record Key

b03fbba3-cf72-4947-a302-1541005f9b23

Public Version Date

May 10, 2021

Public Version Number

2

DI Record Publish Date

September 24, 2018

Package DI Number

34546540052316

Quantity per Package

12

Contains DI Package

04546540052315

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

pack