EPOC HOST, INT'L, JAPANESE, REFURBISHED - Epocal Inc

Duns Number:201179681

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More Product Details

Catalog Number

-

Brand Name

EPOC HOST, INT'L, JAPANESE, REFURBISHED

Version/Model Number

HH-0R03-XU-JP

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 02, 2020

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

-

Product Code Name

-

Device Record Status

Public Device Record Key

1f61eaef-d217-45a8-821a-1c6255183373

Public Version Date

September 16, 2022

Public Version Number

4

DI Record Publish Date

July 05, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"EPOCAL INC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 25