Catalog Number

0295006000

Brand Name

NA

Version/Model Number

0295006000

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

53175a32-919f-49a6-84f6-bdc1a2fd1a73

Public Version Date

May 10, 2021

Public Version Number

3

DI Record Publish Date

July 12, 2017

Package DI Number

34546540052323

Quantity per Package

12

Contains DI Package

04546540052322

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

pack