Catalog Number

678-104

Brand Name

HU-FRIEDY

Version/Model Number

678-104

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

EKD

Product Code Name

INSTRUMENT, CUTTING, OPERATIVE

Public Device Record Key

072e9003-3559-4cd4-994b-3ff67ae3aa8e

Public Version Date

November 20, 2020

Public Version Number

1

DI Record Publish Date

November 12, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-