Catalog Number

-

Brand Name

Espire Elbow Hybrid

Version/Model Number

EEH RCMS IBT

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

July 13, 2021

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

GXY

Product Code Name

Electrode, Cutaneous

Public Device Record Key

dffa66d4-c6d5-4daa-8b1b-dbbd24221d2b

Public Version Date

July 15, 2021

Public Version Number

2

DI Record Publish Date

June 09, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-