Catalog Number

ESO-MM

Brand Name

BMI

Version/Model Number

ESO-MM

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

IQI

Product Code Name

Orthosis, Limb Brace

Public Device Record Key

d693bb00-e604-4a53-b443-cdfd6c85c5d1

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

December 13, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-