Catalog Number

-

Brand Name

EPOC HOST, RX, JAPANESE, REFURB

Version/Model Number

HH-0R10-JP-JP

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 02, 2020

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

-

Product Code Name

-

Public Device Record Key

fc216f9b-c9fd-4bbd-9d49-848199863a17

Public Version Date

September 16, 2022

Public Version Number

4

DI Record Publish Date

July 05, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-