Catalog Number

-

Brand Name

MY01 Continuous Compartmental Pressure Monitor

Version/Model Number

0001

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K202635,K210525

Product Code

LXC

Product Code Name

Monitor, Pressure, Intracompartmental

Public Device Record Key

e3373bd9-6b9b-4900-bd15-79894378309f

Public Version Date

May 10, 2021

Public Version Number

3

DI Record Publish Date

March 01, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-